MY BELGAUM CHEMISTS

BE READY FOR GST.............

2016-11-07T11:51:00.002+05:30

http://www.gstindia.com/gst-council-fixes-4-rate-structure-all-you-need-to-know-about-the-extremely-complex-tax-reform/

PLEASE CLICK ON ABOVE LINK FOR INFORMATION OF GST

Govt exempts antibiotics manufactured before Feb 28 from labelling provisions of Schedule H1

2014-03-22T15:13:00.004+05:30

New Delhi, 21 March 2014: The Union health ministry has allowed the chemists to sell antibiotics listed under the Schedule H1, but manufactured before February 28, without the new labelling requirements even as the notification regarding the antibiotics has come into effect from March 1. However, the chemists have been asked to follow other instructions for the sale of these antibiotics with regard to prescription and maintenance of sale records as per the amended rule under the Schedule H1, according to the official sources. The relaxation was given following the representations by the trade bodies citing difficulties in relabelling of the products manufactured earlier. The Government had notified the amendment to include Schedule H1 under the Drugs and Cosmetics Rules 1945 on August 30, 2013, containing certain antibiotics, anti-TB drugs and habit forming drugs. The notification has come into effect from March 1, 2014, after the stipulated time of six months. “The representations were received from the drug manufacturers associations as well as individual manufacturers that the chemists may not be able to sell the drugs covered under the Schedule HI which are not labelled as per the provisions of the amended rules even though these drugs at the time of their manufacture were labelled in accordance with the rules applicable to them,” said a notice from the Drug Controller General of India (DCGI). “The representations have been considered by the Ministry of Health and Family Welfare and it has been decided that the drugs included in the Schedule H1 manufactured upto February 28, 2014 without the labelling requirements specified in the notification but labelled as per provisions applicable for them at the time of their manufacture, may continue to be sold beyond March 1, 2014. The chemist, while selling the drugs included in Schedule H1 would however be required to comply with the requirements for the sale of drugs covered under the said notification in respect of requirements of sale of these drugs against the prescription of an RMP and maintenance of sales records as specified therein,” the notice said. After dilly-dallying on the issue of antibiotics policy for long, the Government had amended the Drugs and Cosmetics Rules to insert Schedule H1 category to regulate the use of antibiotics in the country, but placing 46 antibiotics under category instead of original proposal to include 91 drugs. The government made it compulsory for these listed antibiotics to carry warning also. “If it contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label,” according to the official notification by the health ministry. Antibiotics falling under third and fourth generation and several habit forming drugs are in the list. Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefixime, Cefoperozone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codein, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Ethambutol Hydrochloride, Ethionamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Rifabutin, Rifampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are the drugs included in the list.

Pharmabiz

SCHEDULE H1 DRUG LIST AND RETAIL BILLING FORMAT

2014-03-14T11:52:00.000+05:30

DCGI puts restrictions on use of tramadol, tapentadol and their FDCs

2014-03-14T11:22:00.001+05:30

New Delhi, 24 Feb 2014: The Drugs Controller General of India (DCGI) has put restrictions on the formulations of tramadol, tapentadol as wells as fixed dose combinations containing tramadol, in line with the recommendations of the new rug advisory committee as these drugs had potential for respiratory depressions and addiction. Formulation of tramadol has been approved by the Central Drugs Standard Control Organisation (CDSCO) on January 27, 1993 for purpose of severe acute and chronic pain, diagnostic measures and surgical pain. Further the formulation of tapentadol had been approved on April 18, 2011 for relief of moderate to severe acute pain in adults 18 years of age or older. “The NDAC (analgesics, anaesthetics and rheumatology) at its meeting held on March 22, 2013 deliberated that tramadol as well as tapentadol has high potential for respiratory depressions and addictions. The committee recommended that all preparations of tramadol as well as tapentadol should be used for severe acute pain only for a period not exceeding five days,” said a directive by the DCGI. “You are therefore requested to direct all the manufacturers manufacturing the preparation containing tramadol or tapentadol under your jurisdiction to comply with the aforesaid indication. The labels, package inserts and other promotional literature of such products should be revised as above and submitted to the Directorate for further necessary action,” the notice sent to all the state licencing authorities said. The DCGI, in his letter, also directed the manufacturers to communicate the changes made and compliance to the amendment to his office. More than 100 companies, mostly lesser known entities, manufacture the painkiller tramadol, while only leading companies are selling tapentadol. However, hundreds of fixed dose combinations involving these two drugs are in the market.

Pharmabiz

Amended Narcotics Drugs Act notified after getting assent from President

2014-03-14T11:20:00.001+05:30

New Delhi, 13 March 2014: The Narcotic Drugs and Psychotropic Substances (Amendment) Act, 2014 (NDPS), which is expected to give access to pain relief medicines including morphine to cancer patients, has been notified by the government after it got the assent from the President. According to official sources, the President gave the approval to the Act recently after the parliament passed the bill during its Winter Session in February, thus paving way for the final notification to put it into effect. The Act has been viewed as a welcome step to help the terminally ill patients get relief as it simplified the licensing for storage of morphine which would give the cancer patients access to it, for the first time since 1985 when the narcotics law was enacted. Due to the lack of access to morphine, it was pointed that the science of pain relief or palliative care is not taught in Indian medical colleges as a specialised degree. At present, the All India Institute of Medical Sciences (AIIMS) and Safdarjung Hospital are the only two hospitals in Delhi and among the few centres in the country that store and prescribe opiates for treating chronic pain in terminally ill cancer and AIDS patients. Morphine, derived from opium, is the only analgesic to manage pain in terminally ill cancer patients. India, despite being one of the largest producers of morphine in the world, has restricted its availability. The Narcotic Drugs and Psychotropic Substances Act earlier prohibited, except for medical and scientific purposes, the manufacture, production, sale and use of opiates. Before this amendment, each state had a different law for opiates. Further, hospitals procuring morphine will now need a single permit instead of the six required before. The licence will be granted by the state drug controller. The bill has been stuck in red tape for a decade. Finally it got clearance after morphine was categorised as essential narcotic medicine, necessitating the need for a uniform, centralised regulation.

Pharmabiz

INTERNATIONAL KITE FESTIVAL AT BELGAUM KARNATAKA........

2014-01-14T20:35:00.000+05:30

परिवर्तनतर्फे १८ ते २१ जानेवारी २०१४ दरम्यान आंतरराष्ट्रीय पतंग महोत्सवाचे आयोजन

बेळगाव,दि . १४:परिवर्तन परिवारातर्फे दि . १८ ते २१ जानेवारी २०१४ दरम्यान आंतरराष्ट्रीय पतंग महोत्सवाचे आयोजन करण्यात आल्याची माहिती संयोजक माजी आमदार अभय पाटील यांनी पत्रकार परिषदेत दिली . नानावाडी ,सावगाव मार्गावरील माळावर होणाऱ्या आंतरराष्ट्रीय पतंग महोत्सवात देशातील आणि परदेशातील पतंगबाज सहभागी होणार आहेत .

दि . १८ रोजी पालक मंत्री सतीश जारकीहोळी यांच्या हस्ते सकाळी १०. ३० वाजता आंतरराष्ट्रीय पतंग महोत्सवाचे उदघाटन होणार असून प्रमुख पाहुणे म्हणून खासदार सुरेश अंगडी ,जिल्हाधिकारी एन . जयराम ,उद्योजक राम भंडारी उपस्थित राहणार आहेत .

आंतरराष्ट्रीय पतंग महोत्सवाचे एरो मॉडेलिंग शो ,क्र्याकर शो आणि नाईट काईट फ्लाइंग हे आकर्षण ठरणार आहे . पतंग उडविण्याच्या कलेला प्रोत्साहन देण्यासाठी मुले तरुण ,महिला आणि कुटुंबांसाठी दि . २० आणि २१ जानेवारी रोजी पतंग उडविण्याची संधी महोत्सवात देण्यात येणार आहे .

आंतरराष्ट्रीय पतंग महोत्सवाच्या निमित्ताने परिवर्तन परिवारातर्फे दि . २० जानेवारी रोजी आंतरराज्य युथ फेस्टिवलचे आयोजन करण्यात आले असून उदघाटन समारंभाला खासदार रमेश कत्ती ,व्ही टी यु चे उपकुलगुरू महेशप्पा ,डॉ . एम . व्ही . जाली ,उद्योजक जयंत हुंबरवाडी आदि मान्यवर उपस्थित राहणार आहेत . कर्नाटक ,महाराष्ट्र आणि गोव्यातील २८ हून अधिक कॉलेजचे विद्यार्थी युथ फेस्टिवलमध्ये सहभागी होणार आहेत .

एड्स जागरुकता ,महिला सबलीकरण ,प्लास्टिकचा वापर टाळा याचा संदेश देऊन समाजात जागरुकता निर्माण करण्यासाठी पथनाट्याचे आयोजन करण्यात आले असून दि . १६ जानेवारी रोजी आर. पी . डी . कॉर्नर येथे पथनाट्याचे उदघाटन महानगरपालिका आयुक्त रवीकुमार यांच्या हस्ते करण्यात येणार आहे .

पत्रकार परिषदेला अभय पाटील यांच्यासमवेत अशोक नाईक आणि परिवर्तन परिवाराचे सदस्य उपस्थित होते .

- See more at: http://indiareflects.com/marathi/?p=31922#sthash.8HKtkXhH.2pI3Pp16.dpuf

Chemists’ body fined Rs. 50 crore for holding pharma cos to ransom

2014-01-07T13:44:00.002+05:30

Mumbai, 3 Jan 2014: The Competition Commission of India has fined the All India Organisation of Chemists and Druggists (AIOCD) Rs 50 crore for using its control over chemists across the country to dictate terms to pharma companies on pricing and distribution. The Competition Commission order issued in December is being seen as the first blow to the cartelisation of AIOCD, which had been using its distribution muscle to force pharma companies to set aside higher margins for medicines, in the process pushing up retail prices of drugs and hurting consumers. The AIOCD also imposed its choices on pharma companies in appointing distributors and stockists across the country and stalled launch of new drugs unless the companies subscribed to its Product Information Service, which is nothing but a booklet listing new products introduced in the market.The Competition Commission order said the AIOCD's activities were in violation of Competition Act, 2002, which protects businesses against unfair trade practices, especially those aimed at building monopolies. The AIOCD is the sole apex organisation of pharmacy shops in the country and has 7.5 lakh members. While a 6-member Competition Commission bench asked the AIOCD to give an undertaking that it would put a stop to these illegal activities, the bench refrained from imposing any penalty. But in a separate order, Justice (retired) SN Dhingra, imposed a penalty of Rs 50 crore on AIOCD, saying that the chemist body had ignored similar directives issued in the past. AIOCD president J S Shinde on Friday said he was aware of the CCI bench order. "The matter is being pursued by our lawyers and we will file an undertaking within the time stipulated by the commission," he said. Shinde, however, claimed that the separate order issued by one of the bench members imposing a fine of Rs 50 crore was not applicable. "Only the order passed by the majority bench will be binding on us." The commission has asked AIOCD to 'cease and desist' from its practice of making it mandatory for drug manufacturers to appoint only those stockists who have a no-objection certificate issued by it. It also directed that AIOCD should not get involved in fixing trade margins or collect of Product Information Service charges from pharma companies. The Food and Drug Administration, which regulates manufacturing and sale of medicines in the state, described the Competition Commission's order as path-breaking. "What the AIOCD was doing was anti-consumer. Under the drug price control order, such practices are illegal. We had pointed this out two years ago and had even registered criminal cases against more than a dozen drug manufacturers," FDA chief Mahesh Zagade told Mumbai Mirror on Friday. The CCI has now asked the pharmacists' body to give an undertaking within 60 days confirming that above 'anti-competitive' practices have been discontinued. The body has also been asked to write to the Organisation of Pharmaceutical Producers of India, and the Indian Drug Manufacturers Association that they do not need the AIOCD NOC to appoint new stockists and that manufacturers, stockists and wholesalers are free to offer discounts to consumers. The Competition Commission action was triggered by a complaint filed by Peeveear Medical Services, a Kerala-based pharmaceuticals distributor. Peeveear had applied to Janssen Cilag Pharmaceuticals in 2010 for distributorship. The manufacturer, after completing all formalities, appointed Peeveear as its distributor in March 2011. But in April, the manufacturer discontinued supply of drugs to Peeveear after informing it by an email that this was being done as the documents submitted by the firm were not authenticated by AIOCD. Peeveear Medical Services then moved the commission alleging that "AIOCD was misuing its dominant position by imposing unfair and discriminatory conditions which limited / denied market access to genuine distributors unless they submit to its diktats." The commission asked its director-general to probe the allegations and submit a report. The report, submitted on December 29, 2011, confirmed that AIOCD issued NOC to pharma companies for appointing new distributors, although there was no such legal provision. The report also observed that AIOCD's say in fixing trade margin was institutionalised in MoUs signed between the chemists' association and pharma companies. AIOCD at times resorted to pressuring companies to stop supplies to retailers who engaged in anti-association activities.

Mumbai Mirror

Knowledge empowerment of pharmacist would drive to achieve Pharma Vision 2020

2013-12-23T14:56:00.002+05:30

Thursday, December 19, 2013, 16:40 Hrs [IST]

Karnataka State Pharmacy Council (KSPC) has been at the forefront of pharmacy trade profession. From the organizing several people-oriented programmes like educating public on various diseases and their management by conducting workshops and seminars, to introduction of online registration, renewal of licences for pharmacists and investing in LED (light emitting diode) display in Bengaluru city, the Council has been leading from the front. The latest is that the Pharmacy Council of India (PCI), through its Education Regulation Committee, has gone in for the revision of the D Pharm syllabus. The Committee has approved the KSPC's newsletters, which are seen as informative and educative reference books for the new syllabus of D Pharm. In an interaction with Nandita Vijay of Chronicle Pharmabiz, DA Gundu Rao, president of KSPC, elaborates about 65th IPC 2013 - 'Pharma Vision 2020: Empowering the Pharmacist': Excerpts:

How do you view the theme of 65th IPC - 'Pharma Vision 2020: Empowering the Pharmacist' ?

Knowledge is biggest empowerment for the pharmacist. Therefore, he needs to remain updates in a fast changing world. If a pharmacist is armed with the technical know-how and the practical exposure, he could chip in with his expertise to society. Today, Indian pharmacists are lacking on only one front, and this is in the area of skill up-gradation. Pharmacist's role is not mere dispensation of medicines, but he needs to be a dependable source of guidance to the patient community.

To begin with, the need of the hour was to update syllabus of D Pharm, in which there has been no change since 1992. The education system was in a bad state, until PCI, through its Education Regulation Committee, finalised the D Pharm syllabus. This will transform the education of the entry level diploma holders in pharmacy. The new syllabus is expected to be enforced from coming academic year, July 2014.

A committee headed by Dr FV Manvi, dean and professor of Pharmaceutics, Dept of Pharmaceutics, KLE University’s College of Pharmacy, Belgaum, has gone in for a major revamp, curriculum update to ensure that the candidates are in sync with the latest developments, along with inclusion of Ayush systems of medicine. In addition, two new subjects - Social pharmacy and Phamaco-therapeutics have been included and are been seen as vital topics in terms of understanding the clinical applications of biochemistry and pathology. This would definitely empower the pharmacists.
A relevant and field-oriented syllabus with a reasonable salary would transform the pharmacists' image. It would help lead them to quality growth path of professionalism. It would see the emergence of cross-functional career opportunities for a diploma pharmacy entrant who in a few years could manage a team of pharmacists in a large pharmacy outlet format. I would also like to add that compared to the western world, there is no importance given to a pharmacist in India.

Could you throw some light on new syllabus of D Pharm course?

Currently, the two-year D Pharm course covers in the first year: Pharmaceutics, pharma chemistry, pharmacognosy, biochemistry and clinical pathology, human anatomy and physiology and health education and community pharmacy. In the second year: Pharmaceutics II, pharmaceutical chemistry, pharmacology and toxicology, pharmaceutical jurisprudence, drug store and business management and hospital and clinical pharmacy are covered.

Now, we have omitted subjects like biochemistry and clinical pathology and health education and community pharmacy from the first year syllabus and replaced with social pharmacy. For this subject, the student will be taught on various diseases including community acquired infections. So long the role of the pharmacist involvement in health camps or event government initiated disease - disorder detection camps was not there. Now, the new subjects are seen as a paradigm shift to boost the candidate’s career prospects.

In the second year, pharmaceutics II, pharmaceutical chemistry, pharmacology and toxicology, pharmaceutical jurisprudence, drug store and business management have been replaced with community pharmacy and management, biochemistry and clinical pathology and pharmaco-therapeutics. Upon completion of the two years course, the candidate will be made aware on the preventive healthcare aspects. It will provide opportunities to them chip in their expertise in hospitals and pharmacy-paramedical training centres. Further, D Pharm holders will also provide services to public to maintain good health - for instance, advises on smoking cessation, immunization and narcotic-psychotropic drug abuse.

The new syllabus will also provide the much needed impetus to skill development enabling enhanced responsiveness to minor ailments. This will create a platform for patient counselling about the disease and medication. Subjects such as phamaco-therapeutics and hospital and clinical pharmacy will ensure the qualified D Pharm to be confident in counselling patients and their relatives on the manifestation of the disease and the different drugs that needed to be administered to control the condition. It will also provide exposure to adverse drug monitoring and clinical pharmacy besides creating openings in departments of pharmacovigilance.

Are you confident that with only these changes, the pharmacist will be empowered?

The practical and theoretical exposure to blood pressure checks, carrying out simple pathology lab tests the pharmacy profession will gain significance and his role cannot be overlooked. It has been extremely disheartening to note that even in the government of India’s Health Policy 2002, there was no mention a pharmacist instead nurses were given more importance. This indicated that efforts needed to be made to ensure that diploma holder or a graduate in pharmacy needed to find a place in the Indian healthcare space. The empowerment of knowledge for the pharmacist was seen to be best way. Now with the revised syllabus and with the first batch of the Pharm D graduates passing out in 2014, we are confident the profession is on its way to gaining limelight.

Coming to Pharm D, what is your view on this qualification?

There is a concern on the employment opportunities for the Pharm D candidates. This is where the government need to mandate that all 50-bed nursing homes and hospitals will need to hire a Pharm D graduate. The move will help to drive several preventive healthcare initiatives. The Pharm D candidate will need to work along with the doctors where he could advice home on the medicines available, it contents, pharmacological contraindications, thwart multiple drug administration and adverse drug reactions. We could see a paradigm shift in the healthcare space if Pharm D candidates service are utilized across medical centres. This is a big benefit for the patient if qualified Pharm D personnel are a part of the healthcare facilities.

Coming to pharma manufacturing front, what are the opportunities for pharmacy graduates?

Here, there is need for an amendment of the D&C Act, because currently a sizeable number of science graduates and postgraduates are employed at drug production plants after extensive training is imparted. This indicates that at many of these facilities, B Pharm, M Pharm candidates do not find a job. Many small- and medium-sized companies recruit a BSc or an MSc so that their services are cheaper than those of a B Pharm, M Pharm. The difference in package is almost double.

As the president of KSPC, what are the visible trends in pharmacy profession that you can highlight?

Pharmacists play a vital role in healthcare. He is a critical component in the healthcare milieu. Once empowered, we would see a drastic change, and he would be playing an important role in the daily activities of doctors - coordinate and cooperate with medical professionals to create a healthy society.

What are the challenges for pharmacy profession?

The biggest challenges for the pharmacy profession are the emergence and establishment of chain shops, since the introduction of foreign direct investment, several multinational chains are on their way to set up shops in the country. This would see the end of existing chemist and druggist outlets. In Karnataka, we have forewarned 28,500 pharmacy trade outlets that they could soon be out of business. The lack of knowledge and the inability to empower the pharmacy diploma holders led us to revise and update the syllabus. These diploma holders need to be taught and kept attuned with the advances like the third generation of cephalosporins, and new drug delivery devices. Further, the Karnataka govt is working to set up generics stores in 176 taluks, and this could further see a dent in sales of the existing chemist and druggist outlets, more so in the districts.

What needs to be done to protect the future of pharmacists?

Knowledge empowerment is the only way to protect the future of pharmacists. This would enable them to tap more job avenues not just in outlets, but at hospitals, industries and centres of pharmacovigilannces. For example, in the case of KSPC, it introduced online registration, renewal of licences for pharmacists in the state. The move follows the Pharmacy Council of India’s validity of expiry date of registered pharmacists' certificate until December 31, 2012. In 2010, the Council also went on to invest Rs. 1.3 lakhs to install LED display in Bangalore city which flashes tips on healthcare, medication usage, and storage methods. The concept is a first-of-its-kind in the pharmacy space in Asia, Now, we are working to expand it.

There is no doubt that the future of pharmacists is bright by the efforts. The new syllabus would ensure higher emoluments and recognition world wide. This would also see the Indian pharmacist marching ahead and achieve the Pharma Vision 2020.

Over Charging of Life-Saving Drugs by Sellers

2013-12-23T11:54:00.002+05:30

New Delhi, 10 Dec 2013 (PIB): The term “Life saving drugs” is not recognized under the Drugs and Cosmetics Act, 1940 and rules made thereunder. However, the Government has published a National List of Essential Medicines (NLEM), 2011 containing 348 medicines. The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e. cost, safety and efficacy. NLEM is one of the key instruments in balanced healthcare delivery systems of the country which includes accessible, affordable quality medicines at all the primary, secondary and tertiary levels of healthcare. Pricing of drugs is administered by the Department of Pharmaceutical and the National Pharmaceutical Pricing Authority (NPPA) under the provisions of the Drug Price Control Order (DPCO). The Drugs & Cosmetics Act, 1940 and Rules made thereunder administered by the Ministry of Health and Family Welfare do not contain provisions for pricing of drugs. Government in that Department has notified the National Pharmaceutical Pricing Policy and the Drugs Price Control Order, 2013 to regulate the prices of essential medicines. This was stated by Shri. Ghulam Nabi Azad, Union Minister for Heath and Family Welfare, in a written reply to the Rajya Sabha today.

Pharmacists urge DCGI to issue clarifications on Schedule H1 to avoid misinterpretation

2013-12-23T11:51:00.003+05:30

Mumbai, 19 Dec 2013: Pharmacists across the country have expressed huge concern over the lack of clarity in the recently published gazette notification on Schedule H1, which deals with regulating the use of antibiotics in the country. Raj Vaidya, a community pharmacist, points out that there are lot of gray areas in the notification that needs to be clarified so as to avoid complications arising due to misinterpretation of some clauses by different persons or authorities. Pharmacists fear that if left unclarified, the present situation may lead to chaos and confusion threatening to cause discomfort to the smooth functioning of the pharmacies. The government had in September amended the Drugs and Cosmetics (D&C) Rules to insert Schedule H1 category to curb the indiscriminate use of antibiotics and some other vital drugs, by placing 46 antibiotics under this category. In a letter addressed to the Drugs Controller General of India (DCGI), Vaidya has urged the Centre to clarify whether the records of sale of Schedule H1 products have to be maintained in a handwritten form, or can it be saved in the inventory or billing software. This demand comes in the wake of confusion in the interpretation of the said clause which fails to stress on how to do it. Vaidya points out that since more that 50 per cent of chemists now use computerised inventory and billing, it would be appropriate that an option may be given to the licencee to keep the records by writing by hand or to collate the records in the inventory software, and take a daily print out of the same and maintain in serial order. Further, to ensure nationwide uniformity in maintaining this he wants the CDSCO to include the exact format of maintaining the Register to be included in the schedule and rules. He also insist that there needs to be more clarity in the area of address of the prescriber which has to recorded in a register as, as there is a confusion among pharmacists over filling the address of the doctor as he or she may be a visiting doctor, or a doctor practising with multiple centres. In his representation he further stressed that the centre needs to urgently clarify whether these new Rules regarding Schedule H1 are applicable to hospitals and nursing homes not having a retail license as well, and whether they have to maintain a separate register for recording the utilisation of Schedule H1 products as specified. “It is very important that these rules are made applicable to them along with doctors dispensing medicines to their own patients covered under Schedule K. This is mainly because the strictness of need for a prescription due to these new Rules, may lead medical practitioners to prescribe a higher quantity of the drug under Schedule H1, on one prescription so that the patient is not faced with inconvenience,” Vaidya said. He pointed out that even the upper limit for number of days of treatment to be prescribed or the maximum quantity to be prescribed per prescription is not specified in the Rules. which he feels is a must, so as to avoid conflict or complications due to misinterpretation and ambiguities. Raising several doubts over the implementation of this rule, he has requested the CDSCO to explain what steps are being taken by them to give clarifications to all the states as well as practitioners of other systems of medicine that the latter are not permitted to prescribe Schedule H1 as well as other allopathic drug.

Pharmabiz

Blood banks can't charge more than rates fixed by NBTC: Gujarat High Court

2013-12-03T13:18:00.003+05:30

Ahmedabad, 1 Dec 2013: Soon, blood banks in Gujarat will be able to sell bloods to public only at the rate fixed by National Blood Transfusion Council (NBTC). They will also be obliged to give free blood to patients suffering from thalassemia and haemophilia. The Gujarat High Court in its landmark judgement on blood banks on Saturday made it clear that it would be the duty of the state government to appoint sufficient number of inspectors to ensure that rules for running of blood banks are strictly complied with as per the National Blood Policy. The court was hearing a public interest litigation (PIL) filed by city-based resident Ashok Naik. During the hearing, the state government had filed an affidavit stating that it has no powers to order an inquiry into the blood donation and distribution channels of blood banks. The HC also noted that it was apparent that blood banks were not following the guidelines on rates prescribed by NBTC and were charging patients arbitrarily. “All blood banks must display a rate card of the blood for patients as per NBTC rates,” the court said in its order. “We are of the opinion that strictest possible action should be taken against blood banks violating the guidelines, directions, conditions or regulations...,” the court observed. The bench comprising chief justice Bhaskar Bhattacharya and justice JB Pardiwala also directed setting up of a high-level committee headed by additional chief secretary, health, from government of Gujarat. The nine-member committee will include an expert in blood transfusion, secretary heath expenditure from finance department, head of pathology department of BJ Medical College and commissioner of foods and drugs administration of the state. The court directed the committee to look into eight broader guidelines (see table) while preparing its report. The guidelines are likely to prevent the opaque nature in which the blood banks operate at present. They clarify the definition of profiteering, collection and distribution of blood as well as mandate inspection and audit of the blood banks in the state. The committee has been directed to submit its report within two months. The HC will look into the report in the first week of February 2014. The PIL has alleged that some blood banks, specifically Ahmedabad-based Prathama Blood Bank, are profiteering by selling plasma and platelets. In its order the HC did not find the allegation to be correct. “We have already indicated that maximum demand is for red blood cells and the amount received from the sale of blood plasma or platelets is much less than what one receives by supplying red blood cells. Therefore, after supply of red blood cells, if the rest of the blood components are given for manufacture of plasma or platelets, the same cannot be objected to for any reason,” the court order read. In case of Prathama Blood Bank, the allegations in the PIL have been partly accepted by the court. “It further appears that Prathama has been given land by the Ahmedabad Municipal Corporation (AMC) at the rate of Rs101 per annum for 99 years. One of the conditions set out as part of the aforesaid transaction was that the blood bank should give 10% of all blood collections free-of-cost to hospitals run by AMC and the balance requirement of the hospitals run by the AMC shall be fulfilled by giving blood at 30% discount from the prescribed rate. In such circumstances, we direct the AMC to strictly implement the above conditions and to give a report. If it appears that Prathama has committed breach of the condition, the same amounts to illegal enrichment of money, therefore, in such circumstances, the AMC should recover the amount of illegal enrichment,” the court ruled. Guidelines to Committee Every blood bank in state should earmark percentage of total blood collection to be supplied free of cost to govt or municipal hospital Ensure appointment of sufficient number of inspectors Ensure that no blood bank in state indulges in profiteering or charge more than the rate prescribed by the ministry of health and family welfare Evolve a policy to make it clear as to what constitutes profiteering, what is the offence of profiteering and what should be its penal consequences. Ensure that audit of blood banks is undertaken on a regular basis Ensure strictest possible action against the blood banks found to be violating the guidelines Ensure that all government and municipal hospitals conduct blood donation camps regularly based on assessment of the requirement. Look into all other relevant aspects relating to blood banking In a landmark judgement, Guj HC rules that it is state’s duty to ensure blood banks comply with National Blood Policy guidelines; appoints a committee to ensure full implementation of the order.

DNA

80% of medicines not covered by price control order

2013-12-03T13:04:00.001+05:30

New Delhi, 1 Dec 2013: About 38 million people in India (which is more than Canada's population) fall below the poverty line every year due to healthcare expenses, of which 70% is on purchase of drugs. Yet, the much-awaited drug price control order (DPCO) 2013, meant to control the price of medicines does not cover over 80% of the medicines in the market. Many drugs crucial for India's disease profile have been left out, which means people are unlikely to see any significant reduction in expenditure on medicines. In 2003, the Supreme Court, while hearing a case on the National Pharmaceutical Pricing Policy, had directed the government to formulate appropriate criteria to identify essential and life saving drugs and ensure that they came under price control. It took over a decade for the government to announce the DPCO in May 2013. By the government's own admission in an affidavit filed in court, the market value and share of medicines covered by DPCO is just 18% of the country's pharma market. Many life-saving medicines including anti-cancer drugs, expensive antibiotics and drugs needed for organ transplantation have been left out. The government merely lifted the entire National List of Essential Medicines (NLEM) 2011, comprising 348 medicines, and placed it under price control. "The literal translation of the NLEM into DPCO 2103 has been done without a thought of its implications. The companies have been provided a convenient escape route. A 500 mg Paracetamol tablet is under price control but its 650 mg strength is not; individual anti-TB drugs are under price control but their combinations which outsell single ingredient preparations are not. This undermines the entire objective of making essential medicines more affordable to Indians," explained Dr Anurag Bhargava, associate professor at the Himalayan Institute of Medical Sciences. He stressed the need to expand the scope of price control to include all dosages and combinations, as was the case in the previous DPCO of 1995. With the current DPCO not covering combinations of drugs, a lot of drugs for diabetes and hypertension and many other conditions will move out of price control as they are used in combination. The combinations not covered under NLEM account for Rs 31,866 crore or almost 45% of the total pharma market of Rs 71,246 crore in 2012. An independent evaluation of the National Pharmaceutical Pricing Policy, by the Public Health Foundation of India (PHFI) and the Institute for Studies in Industrial Development (ISID) for a forthcoming report explains why it is important to expand the scope of price control. According to their evaluation, the market value of anti-infectives under price control is Rs 4,636 crore, just 6.5% of the total market. Anti-infectives, which include antibiotics, have the biggest chunk of India's pharma market. "Our evaluation shows that if price control was expanded to combinations, additional strengths and dosages of just the anti-infectives included in the NLEM, the total market value would be worth more than Rs 10,500 crore, about 15% of the total pharma market, a vast improvement over the current coverage of just 6.5%," said Malini Aisola of PHFI. The essential medicines list does not seem to have taken into account India's disease profile as it leaves out several drugs crucial for treating many common conditions, pointed out Dr Bhargava. The government's own affidavit admits that only 18% of anti-diabetics, 19% of anti-TB medicines and 6% of the respiratory therapeutics segment are under price control. This is despite India being the diabetes and TB capital of the world, and facing high prevalence of asthma and chronic obstructive pulmonary disease (COPD). There's good reason why we need price controls. The MRP charged by companies is often many times the cost of production leaving them with profit margins unheard of in any other sector. Price control was meant to address this problem, particularly in medicines important for India. But it has failed to make any significant difference. One reason is the way prices are determined under the current DPCO. Under the 1995 DPCO, the drugs prices under controls was decided by taking the cost of manufacture and fixing a certain percentage as mark-up, which included packaging and distribution costs, retailers' margin, excise duty and profit. But the current DPCO uses a new formula under which the price is fixed by taking the average price of brands having one per cent or more of market share and adding 16% as retail margin.

Times of India

Press Conference................

2013-12-03T12:56:00.001+05:30

NPPA revises prices of 63 more formulation packs under new DPCO

2013-11-11T21:25:00.002+05:30

New Delhi, 9 Nov 2013: The National Pharmaceutical Pricing Authority (NPPA), which has been revising the prices of essential medicines in accordance with the new Drug Price Control Order, 2013 since June this year, has fixed the prices of 63 more formulation packs. With this, the total number of formulation packs covered under the new pharmaceutical policy has crossed 400, including over 50 packs whose prices could not be revised as information was not available. The price regulator had already announced the new prices for over 300 formulation packs already. According to the new pricing policy, the ceiling of prices are fixed based on the simple average of the prices of all brands of that drug that have a market share of atleast one per cent. The national list of essential medicines lists 348 bulk drugs, which are sold as 650 formulations. The formulation packs for which prices were revised are based on magnesium sulphate, phenytoin sodium, clotrimazole, acyclovir, clindamycin, cyclosporine, L- Asparaginase, melphalan, mercaptopurine, paclitaxel, procarbazine, vinblastine sulphate, daunorubicin, chlorambucil, phytomenadione, Dextran-40, Factor VIII concentrate, omeprazole, hyoscine butyl bromide, condoms, diphtheria antitoxin, rabies immunoglobin, hepatitis b vaccine, measles vaccine, chloramphenicol, thiopentone sodium, desferrioxamine mesylate, praziquantel, isoniazid, clotrimazole, efavirenz, ritonavir, diloxanide furoate, sodium stibogluconate, busulphan, etoposide, folic acid, hydroxyethyl starch (Hetastarch), digoxin, 5-amino salicylic acid (5-ASA), bisacodyl, ethinylestradiol, antitetanus human immunoglobin, neostigmine, betaxolol hydrochloride, terbutaline sulphate, lignocaine hcl, sulphacetamide sodium, sulphacetamide sodium, and azithromycin. The combination drugs like glibenclamide + metformin HCL, olmesartan medoxomil + metoprolol succinate, olmesartan, edoxomil + metoprolol succinate, telmisartan + metoprolol succinate, amoxycillin + potassium clavulantate, cefixime trihydrate+ ornidazole, voglibose + metformin hcl, ceftriaxone sodium + sulbactum sodium, and voglibose + metformin hcl were also among those. Apart from this, the agency also revised the prices for paracetamol drops and cefixime drops.

Pharmabiz

60 drug cos offer increased margins to trade on controlled drugs after talks with AIOCD

2013-11-11T21:20:00.000+05:30

Mumbai, 11 Nov 2013: Over 60 drug manufacturers have agreed to increase trade margins of wholesalers and retailers on price controlled medicines after a series of talks between various industry bodies and All India Organisation of Chemists and Druggists (AIOCD). AIOCD had to initiate talks with the industry bodies as Department of Pharmaceuticals (DoP) has been hesitant to restore the old trade margins by amending DPCO 2013. Says Suresh Gupta, general secretary, AIOCD, "We look forward to getting an increase in the trade margin from over 90 companies for which talks are still going on." AIOCD office bearers made a representation on October 25, 2013 to NPPA to address the demand of the trader community to get the trade margin of 20 per cent and 10 per cent for retailers and wholesalers respectively. After the meeting with the AIOCD representatives and the industry, NPPA directed the trade body to come out with a consensus on the issue within a period of one month. As per the list released by AIOCD, amongst the big pharma companies which have agreed to offer higher margins include Blue Cross, Franco Indian, Delcure Lifesciences, RPG Lifesciences, Systopic Laboratories Pvt Ltd, Cipla Ltd, Torrent Pharmaceuticals Ltd, Mankind Pharma Ltd, FDC Ltd, Hetero Healthcare Ltd, Indoco Remedies Ltd, Macleods Pharmaceutical Ltd, Eris Lifesciences, Medley Ltd, Emcure Pharmaceuticals, Zuventus Healthcare, Jenburkt Pharmaceuticals, Morepen Laboratories Ltd, Molekule Lab, Merck Ltd, Neon Laboratories Ltd, Wallace Pharmaceuticals Pvt Ltd, Ranbaxy Laboratories Ltd, Lupin Ltd, Alkem Lab Ltd, Helios Pharmaceuticals, Apex Lab and Troikaa Pharmaceuticals Ltd. Stockists and retailers have been arguing that their margins have come under severe pressure after implementation of the new price control order. Industry associations and trade bodies across the country also maintain that the government must look for ways to compensate stockists adequately. The new price control mechanism had earlier led the retailers to refrain from buying stocks of essential medicines leading to inconsistent supply of medicines in the market. The DPCO 2013, which came into effect from May, 2013 reduced the trade margin on essential medicines, while increasing the span of price control. Under the earlier DPCO, 1995, retailers and wholesalers were entitled for a minimum margin of 16 per cent and eight per cent, respectively, on controlled medicines. And on drugs outside price control, retailers were allowed a minimum margin of 20 per cent, whereas wholesalers were entitled a margin of 10 per cent. However, with the new DPCO in place, retailers and wholesalers have taken a double hit. More drugs have come under the scheduled category, whereas margins are lower. Also, the margins are squeezed from 16 per cent to 13.79 per cent for retailers and from eight per cent to seven per cent for wholesalers. Besides, the new DPCO also prescribes a different formula to calculate the margins.

Pharmabiz

DoP asks NPPA to relook at ceiling price fixed for azithromycin under new DPCO

2013-11-09T10:27:00.002+05:30

New Delhi, 31 Oct 2013: The National Pharmaceutical Pricing Authority (NPPA) has been directed by the Department of Pharmaceuticals (DoP) to reconsider the ceiling price fixed for Zithrox and Azilide brands of azithromycin produced by Alembic Pharmaceuticals Ltd., following a review petition filed by the company against the NPPA revision as per the new Drug Price Control Order, 2013. However, the review petitions by Modi-Mundipharma Pvt Ltd and Win-Medicare Pvt Ltd were rejected by the DoP as many more companies have reportedly challenged the new ceiling prices announced by the NPPA in line with the DPCO and the pharmaceutical pricing policy in the recent months. “NPPA is requested to have a relook on data of Zithrox and Azilide with PTR (price to retailer) Rs.4.16 and Rs.6.81 as brought out during the hearing in consultation, with the IMS Health and if there is any basis for revision, the price may be revised accordingly,” according to an order by the DoP recently. Alembic Pharma had challenged under para 31 of DPCO the order (S.O. No. 1577(E) dated 14.6.2013) the new ceiling price of azithromycin 500 mg tablets. “The issues involved in the review application have been examined based on the record of note of discussions of the personal hearing and other documents on record,” the order said. Win-Medicare has challenged the NPPA price fixation (S.O. NO. 1651(E) dated June 14, 2013) for fixing ceiling price of scheduled medicine povidone iodine solution five per cent. But the DoP has rejected the petition after hearing the case. “Review application of the Petitioners is disposed of on the grounds that price fixation by NPPA is as per the provisions of DPCO, 2013,” said the order in this regard. Likewise, the challenge by Modi-Mundipharma also against the NPPA same order (S.O. NO. 1651(E) dated June 14, 2013) for fixing ceiling price of the same formulation of povidone iodine solution five per cent was rejected by the Department.

Pharmabiz

After HC disallows ban, govt to put warning on anti-depressant

2013-11-09T10:25:00.002+05:30

New Delhi, 6 Nov 2013: Left red-faced after yet another drug ban order failed to pass judicial scrutiny, the government is set to pass an order that anti-depressant Deanxit should be sold with a warning in red that the drug is to be sold only on the prescription of a registered psychiatrist. A notification regarding this will soon be issued under section 26A of the Drugs and Cosmetics Act. In addition, an expert committee comprising psychiatrists and pharmacologists constituted by the Drug Technical Advisory Board will examine the safety and efficacy of the drug and make recommendations about its marketing in India. The move comes after the Health Ministry's June order suspending manufacture and sale of Deanxit — a fixed drug combination of flupenthixol and malitracen — in India was quashed by the Karnataka High Court in August. The court passed the order on a petition by the drug's Danish manufacturer, Lundbeck, and Mankind Pharma, the company marketing it in India. Deanxit was approved in India about 15 years ago, but the decision was termed illegal by the Parliamentary standing committee of health and family welfare in its 66th report last year on the ground that it leads to abnormal heart rhythms and neurological side-effects. The committee also took exception to the fact that Indians were being exposed to a drug that is banned in its country of origin, Denmark. The company was then given six months to prove the drug's safety and efficacy. When the relevant documents were submitted, questions were raised about the sample size, trial protocol, trial site, etc. But when the matter went to the Karnataka HC, the drug controller failed to defend the expert committee's decision. The quashing of the Deanxit order follows the Health Ministry's revocation of two more such orders on painkiller Analgin and diabetes drug Pioglitazone, which drew fierce opposition from a section of doctors. The ministry also failed to justify the orders before an expert committee, thus exposing loopholes in the drug regulation mechanism.

Indian Express

SHRI K.E.PRAKASH PRESIDENT KCDA AT.............

2013-11-09T10:06:00.002+05:30

Belgaum(9/11/2013)-On the Occasion of Annual Gen.Meeting of "Belgaum District Welfare Chemist & Druggists Association,Belgaum(Karnataka)held on 10/11/2013,Shri K.E.PRAKASH president of Karnataka State Chemists & Druggists Association with office bearers will inaugurate the function.Also he will address to the members of the BDWCDA.
On this occasion Shri Rajshekhar Malli (Asst.Drugs Controller of Belgaum circle) and Shri K.S.Mallikarjun(Asst.Drugs Controller of Karwar cicle) will guide about the amendments in Drugs & Cosmetics rules.
Talking with Belgaum Chemist Blog,Shri Gangadhar Turmundi,Secretary of the Association briefed the Successful Activities of the Association,like Solving problems of wholesale distributors,Retail Members.Also by circulating Important circulars about Rules& Regulations of Drug & Cosmetic Act 1940,Vat circulars time to time.In coming days Association is arranging Education Programmes for their Members.

More large pharma cos offer higher trade margins over DPCO 2013

2013-10-07T21:05:00.003+05:30

Mumbai, 28 Sept 2013: Shortage of essential medicines on retail shelves may be over soon as nine pharma companies in succession over the past two months have agreed to offer higher margins to the retailers and stockists against what has been mandated in the DPCO-2013. AIOCD has been in the process of approaching over 100 companies with similar demands over the past couple of months. Taking cue from Mumbai-based Blue Cross Laboratories Ltd, Franco-Indian Pharmaceuticals Pvt Ltd, RPG Life Sciences, Delcure Life Sciences and Modi Mundipharma, Mumbai based Macleods Pharmaceuticals Ltd, Hetero Healthcare Ltd, Indoco Remedies Ltd and FDC Ltd will also offer higher margins of 20 per cent and 10 per cent to retailers and stockists respectively as demanded by trade body All India Organisation of Chemists and Druggists (AIOCD). In a letter dated September 24, 2013, Rajeev Mishra, vice president, Field Operations and Distribution, Macleods Pharmaceuticals Ltd. informed that effective September 25, 2013 all our stockists and retailers shall get their trade margins on our products same as before implementation of new DPCO 2013. This in effect means no change in trade margins and all those products that have come under new DPCO shall continue to get 10 per cent stockists margin and 20 per cent retail margin on them with effect from September 25, 2013. As per the circular on the increase in trade margins for NLEM products by Mumbai based FDC Ltd dated September 21, 2013 Shivaji Nalawade, general manager, Logistics, FDC Limited stated that FDC stockists will get trade margins of 10 per cent and retailers will get 20 per cent on all NLEM products. Indoco Remedies Ltd has also offered trade margins of 10 per cent to stockists and 20 per cent to retailers on all NLEM products as per DPCO 2013. William D'Souza, senior executive, Sales and Administration, Indoco Remedies stated in the letter dated September 24, 2013, "We will reimburse the difference in the form of Credit Notes on purchase done by the stockists and retailers of our NLEM products from September 1 to 23 with eight per cent and 16 per cent margin." PC Khasgiwal, vice president, Hetero Healthcare Ltd in a letter dated September 23 has announced trade margins of 10 per cent and 20 per cent to stockists and retailers respectively. He has requested for cooperation and support in maintaining inventories of products adequately to service the market requirements. As per DPCO 2013, the retailers’ margin for all the scheduled (controlled category) products is 16 per cent on price, inclusive of excise duty. Earlier this was on MRP excluding VAT and excise duty. The stockist margin on controlled products was eight per cent excluding excise duty. The new price control order has reduced the net margins for retailers and wholesalers by four and two per cent respectively which the trade feels will not be commercially viable for them.

Pharmabiz

Parliamentary panel starts scrutiny of Drugs & Cosmetics (Amendment) Bill, 2013

2013-10-07T21:03:00.003+05:30

New Delhi, 30 Sept 2013: The Parliamentary Standing Committee on Health and Family Welfare has started examining the new Drugs and Cosmetics (amendment) Bill, 2013 which was presented in the Rajya Sabha last month, seeking to centralise the licensing system in 17 categories of drugs. The Panel headed Brajesh Pathak is learnt to have already kicked off the process and took the views of the Secretary of the Department of Health and Family Welfare recently, after the bill was referred to the committee by the Rajya Sabha. The bill which seeks to set up the Central Drugs Authority was introduced on August 29 in the Parliament. However, the bill was not taken for discussion by the Rajya Sabha till it adjourned sine die on September 6, 2013. Later the bill was referred to the Parliamentary committee on September 9, 2013 for examination and report thereon within a period of two months. Apart from taking the views of the senior Health Ministry officials, the panel has also invited suggestions and comments from the stakeholders on the bill. The panel will also meet the interested stakeholders, including the public, for taking oral evidence during the course of examination. Revising the now-defunct bill of 2007, the new bill seeks to centralise licensing in 17 categories of very critical drugs included in the proposed Third Schedule of the Act. A separate Chapter containing regulatory provisions for medical devices and more comprehensive provisions for regulating clinical trials and exports are included in the bill. It has also revised composition of the Central Drugs Authority consisting of, inter alia, Secretaries of seven Ministries and Departments of the Central Government, four State Drugs Controllers and four experts, with the Drugs Controller General (India) as its Member-Secretary. “In order to have wider consultations, the Committee has decided to invite written memoranda containing suggestions/views/ comments of individuals/institutions/organisations interested in the subject matter of the Bill,” the panel said in a notice.

Pharmabiz

New drug pricing policy under SC scanner

2013-10-07T21:01:00.002+05:30

New Delhi, 4 Oct 2013: The government's new drug pricing policy came under the scanner Thursday as the Supreme Court sought an explanation over the latest pricing formula for essential medicines and questioned if market driven forces had an effect on it. A Bench led by Justice G S Singhvi said it will "test" the rationale behind the new Drug Price Control Order to fix the ceiling price of essential medicines on the basis of average market-based pricing. It demanded an answer on why the new policy, which intends to put a cap on prices of 348 medicines, changed the formula for deciding the cap from a cost-based mechanism to a market price-based mechanism. "This DPCO will encourage profiteering of medicine brands prescribed by the doctors. It seems the government is being guided by market-driven forces. You will have to explain the rationale," the Bench said. Additional Solicitor General Sidharth Luthra denied that it will lead to higher drug prices, saying the policy barred companies selling cheaper drugs from raising their prices significantly. But senior advocate Colin Gonsalves, appearing for the petitioner, NGO All-India Drug Action Network, alleged that under the new policy the margin of profit for manufacturers and dealers has increased. The court asked him to place the data by Tuesday when the case will be taken up for further hearing.

Indian Express

NPPA fixes prices of 43 more formulation packs as per new DPCO

2013-09-27T21:06:00.002+05:30

New Delhi, 25 Sept 2013: The National Pharmaceutical Pricing Authority (NPPA), continuing its exercise of revising the prices of essential medicines under the new Drug Price Control Order, 2013, has fixed the prices of 43 more formulation packs. The formulations are based on the bulk drugs of allopurinol, dexchlorpheniramine maleate, promethazine, phenobarbitone, piperazine, dapsone, ethambutol, isoniazid, acyclovir, didanosine, stavudine, diltiazem, nifedipine beclomethasone dipropionate, hydrocortisone sodium succinate, ipratropium bromide, fluconazole, sevoflurane, bupivacaine hydrochloride, lignocaine hydrochloride, adrenaline, morphine sulphate, heparin, sodium, calamine lotion, glutaraldehyde, sulphacetamide sodium, pilocarpine, ringer lactate, sodium bicarbonate, calcium carbonate, calcium gluconate, diclofenac and cefixime trihydrate+ofloxacin. So far, the NPPA had earlier revised the prices of over 300 formulations in five batches, after the new DPCO was notified based on the new pharmaceutical pricing policy. The new prices will be made into effect after the stipulated window period of 45 days. According to the new pricing policy, the ceiling of prices is fixed based on the simple average of the prices of all brands of that drug that have a market share of at least one per cent. The national list of essential medicines lists 348 bulk drugs, which are sold as 650 formulations. “All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013,” the notification said. The regulator also withdrew an earlier notification. “In exercise of the powers, conferred by paragraph 4, 11 and 14 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby withdraw the Gazette Notification S.O. No. 2534(E) dated 21st August, 2013, relating to cefixime trihydrate+ ofloxacin tablets, with immediate effect,” it said.

Pharmabiz

Schedule H1 Notified on 30 Aug, 2013

2013-09-22T13:24:00.004+05:30

New Delhi, 30 Aug 2013: Ministry of Health and Family Welfare, New Delhi on 30 Aug, 2013 vide GSR 588 (E) has notified Schedule H1 after consultation with DTAB. These Rules will come in force after six months of publication in official Gazette.
In Rule 65, in condition (3), (9), (11) (11A) wherever Schedule H is their “Schedule H and Schedule H1” shall be substituted.

In Rule 97 in sub rule (1) a provision is made that the formulation containing substance specified in Schedule H1, the drug formulation shall be labelled with symbol Rx which shall be in red and conspicuously displayed in the left top corner of the label and shall also be labelled with following Box warning:

“Schedule H1 Drug-Warning

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of a Registered Medical Practitioner,”

In Schedule H, Alprazolam, Cefdinir, Cefepime HCl, Cefetamet Pivoxil, Cefpirome, Cefpodoxime Poxetil, Ceftazidime Pentahydrate, Ceftizoxime Sodium, Chlordiazepoxide, Clofazimine, Codeine, Diazepam, Diphenoxylate and its salts, Ethambutol HCl, Ethionamide, Levofloxacin, Meropenam, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Pyrazinamide, Sparfloxacin, Thiacetazone, Tramadol HCl, Zolpidem entries are omitted.
In Schedule H1, following drug substances and their salts excluding those intended for topical or external use (Except ophthalmic and ear or nose preparations) Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefexime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codeine, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Etambutol HCl, Ethinamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Ribabutin, Rafampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are covered.

HC relief for J&J, can restart production at Mulund factory

2013-09-22T13:21:00.003+05:30

Mumbai, 19 Sept 2013: In a relief for the baby products maker Johnson and Johnson (J&J), the Bombay High Court today allowed the company to restart the manufacturing of baby powder at its Mulund unit, which had been stopped upon the order of Maharashtra Food and Drug Administration. FDA had ordered shut down of the plant for not treating a batch of talcum powder for ethylene oxide residue in 2007. The division bench of Justices S J Vazifdar and K R Shriram was hearing a petition filed by Johnson and Johnson challenging the June 24 order of FDA appellate authority. While allowing resumption of production, court today referred the matter back to the appellate authority for a reconsideration, saying that "the proportionality (of the punishment vis a vis the offence) issue needs to be seen". In March, FDA cancelled the licence of the Mulund factory after it found that 15 batches of baby talcum powder manufactured there in 2007 were sterilised using ethylene oxide, a chemical that is widely believed to be carcinogenic. FDA alleged that the company did not register the process with it, and failed to conduct tests for traces of ethylene oxide in the powder. The company challenged the order, but in June the cancellation of license was upheld by the FDA's appellate authority. Senior counsel Rafiq Dada, appearing for the company, said the company was not using ethylene oxide treatment process anymore. FDA counsel Ashutosh Kumbhakoni had, however, opposed the petition and said the company had not expressed any remorse even after the issue came to light.

Business Standard

National Antibiotics Policy

2013-09-22T13:19:00.002+05:30

New Delhi, 27 Aug 2013 (PIB): The Government has already framed a comprehensive policy, namely, the National Policy for Containment of Antimicrobial Resistance, to address the problem of multi-drug resistance due to widespread and indiscriminate use of antimicrobial / antibiotic drugs in the country. The policy was developed by a Task Force constituted under the chairmanship of Director General of Health Services to address the problem. The policy is available on the web-site of the Ministry of Health & Family Welfare. The salient features of the policy are as follows: To review the current situation regarding manufacture, use and misuse of antibiotics in the country. To recommend the design for creation of a national Surveillance System for Antibiotic Resistance To initiate studies documenting prescriptions patterns & establish a Monitoring system for the same. To enforce and enhance regulatory provisions for use of antibiotics in human & veterinary and industrial use. To recommend specific intervention measures such as rational use of antibiotics and antibiotic policies in hospitals Diagnostic Methods pertaining to antimicrobial Resistance Monitoring Government has decided to initiate steps for the containment of antimicrobial resistance in the country through 30 lab networks and awareness activity for rational use of antibiotics. The aforesaid Task Force had also recommended insertion of a separate schedule under the Drugs & Cosmetics Rules to regulate the sale of antibiotics, especially 3rd and 4th generation antibiotics in the country. In pursuance of that recommendation, the Government issued a draft notification GSR 228 (E) dated 20-03-2012 for inviting comments from the public proposing to insert a new Schedule in the Drugs & Cosmetics Rules, 1945 containing habit forming drugs and certain Anti-TB drugs along with antibiotics. The container of the drugs covered under new Schedule will be labelled with a symbol `Rx` which shall be in red colour and conspicuously displayed on the left corner of the label with the warning - `It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the Registered Medical Practitioner. This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Lok Sabha today.