Pharmaceutical News Live

Supreme Court Directs Centre to Form Committee on Unethical Pharmaceutical Marketing Practices

2026-10-08T23:00:11.054-07:00

Government Acknowledges Need for Stronger Regulation

The Centre acknowledged the need to strengthen the existing regulatory mechanism to prevent pharmaceutical companies from engaging in unethical marketing activities.

According to the government’s submission, detailed discussions had taken place to explore possible solutions. The proposed committee was to examine whether a statutory framework was necessary and, if so, recommend the appropriate legal provisions to ensure ethical practices across the pharmaceutical sector.

UCPMP 2024 to Remain Applicable

Pending the committee’s report and the government’s subsequent decision, the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024, will continue to govern pharmaceutical marketing practices, as stated by the Centre before the Court.

The development could prove significant for pharmaceutical companies, marketing teams, medical representatives and healthcare professionals, as the proposed recommendations may influence the future regulatory framework for pharmaceutical promotion in India.

The committee’s recommendations and the government’s subsequent response will be important developments to watch in the ongoing effort to strengthen ethical standards in pharmaceutical marketing.

Source: Supreme Court proceedings and submissions made by the Central Government, as reported in the news report.

Disclaimer: This article is an editorial rewrite of the supplied news report. Readers should refer to the relevant court order and official government communications for authoritative details.

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FDA Announces Nationwide Recall of Vitruvias Therapeutics Thyroid Tablets

2026-08-25T02:24:16.928-07:00

August 25, 2026 | Pharmaceutical Regulatory & Drug Safety News

The U.S. Food and Drug Administration (FDA) has published a nationwide recall announcement concerning one lot of Vitruvias Therapeutics, Inc.’s Thyroid Tablets, USP 30 mg, after testing confirmed the potential for the product to be superpotent.

Vitruvias Therapeutics initiated the voluntary recall of Lot No. 504950 to the consumer level. The FDA published the company’s recall announcement on August 24, 2026.

Product Details

Product: Thyroid Tablets, USP 30 mg
NDC: 69680-166-00
Lot Number: 504950
Expiration Date: September 30, 2026
Units Released: 3,655
Units Sold: 1,955
Distribution: Nationwide in the United States
Distribution Period: January 31, 2025 – September 30, 2025

Reason for Recall

The recall was initiated because testing confirmed the potential for the product to be superpotent, meaning that the tablets may contain excessive levels of thyroid hormones.

Thyroid Tablets, USP are a natural thyroid preparation derived from porcine thyroid glands and contain levothyroxine (T4) and liothyronine (T3). They are used for the treatment of hypothyroidism.

Exposure to excessive thyroid hormone levels may result in hyperthyroidism, with potential symptoms including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heartbeat and heart-rhythm disturbances.

The FDA identifies elderly patients, pregnant women and infants, particularly with prolonged exposure, as populations that may face greater risks from excessive thyroid hormone levels.

Important Advice for Patients

Patients currently taking Thyroid Tablets, USP from Lot 504950 should not discontinue the medication without first consulting their healthcare provider. Patients should contact their healthcare provider for further guidance and/or a replacement prescription.

Vitruvias Therapeutics stated that, to date, it has not received reports of adverse events known to be related to this recall. The company is notifying wholesalers and arranging for destruction of the recalled product.

Regulatory Significance

The recall highlights the importance of potency control, finished-product testing and ongoing quality surveillance for drug products containing thyroid hormones, where relatively small variations in active pharmaceutical ingredient content can have clinically significant consequences.

For pharmaceutical manufacturers and quality professionals, the case reinforces the importance of robust assay testing, content uniformity, stability monitoring, batch-release controls and pharmacovigilance systems.

Source: U.S. Food and Drug Administration (FDA), Vitruvias Therapeutics, Inc. recall announcement, August 2026.

Centre Proposes Overhaul of Drug & Medical Device Regulation Under New Bill

2025-10-15T22:28:00.000-07:00

The government is developing a legislative overhaul to strengthen regulation across drugs, medical devices, and cosmetics. The proposed Drugs, Medical Devices and Cosmetics Act, 2025 is intended to replace the decades‐old 1940 Drugs and Cosmetics Act and introduce more stringent controls over the sector.

At a high‐level meeting chaired by the Health Minister, the Drugs Controller General of India (DCGI) presented a draft of the new law. The reforms aim to empower the Central Drugs Standard Control Organisation (CDSCO) with statutory authority, tighten market surveillance, and enhance accountability across the regulatory ecosystem.

Key features of the draft legislation include:

Granting CDSCO the power for immediate enforcement actions against substandard, counterfeit, or falsified drugs and devices.
Digitization of licensing processes to streamline approvals and oversight.
Strengthened coordination between central and state regulators.
Upgrading laboratory infrastructure and testing capacity to ensure robust quality control.
Mandatory transparency and traceability throughout the manufacturing-to-market supply chain.

A key impetus behind the reform is growing concern over product safety. India has faced scrutiny following cases such as child fatalities from contaminated cough syrup in Madhya Pradesh.

According to CDSCO’s 2023–24 data, about 3.2% of around 5,500 tested drug samples were found substandard or spurious, leading to enforcement actions at over 40 manufacturing units in recent years.

The government is expected to introduce the bill in the upcoming Winter Session of Parliament. If enacted, the law would align India’s regulatory framework more closely with global standards, boosting confidence in pharmaceutical and device exports.

Abbott Issues Nationwide Alert Over Fake Amoxyclav Batches Detected in Indian Market

2025-10-15T21:53:00.000-07:00

Global healthcare major Abbott Laboratories has issued a nationwide alert to its distributors and stockists in India after fake batches of its popular antibiotic Amoxyclav 625 were found circulating in the market. The move comes amid growing concerns over the prevalence of counterfeit and substandard medicines in the Indian pharmaceutical supply chain.

Fake Batches Identified and Withdrawn

According to a communication accessed by us, Abbott’s pan-India franchise partner, Biomech Healthcare, circulated an urgent notice to all distributors, directing them to immediately stop the sale, purchase, or stocking of three specific batches of Amoxyclav 625 (10 tablets pack) — namely MFK0076, MKFO692, and MKF0722.

These batches, the communication said, have been “confirmed fake or counterfeit”, and distributors have been “strictly instructed not to procure, stock or sell them under any circumstances.”

The notice reads:

“We bring to your attention that Amoxyclav 625 10s batches MFK0076, MKFO692 and MKF0722 currently in circulation are confirmed fake or counterfeit. Please take necessary actions to protect public health and avoid any potential liability.”

Abbott’s official response to media queries on the issue is still awaited. However, the internal advisory highlights that the company is treating the matter with utmost seriousness and has taken the step as a precautionary measure to protect patient safety and product integrity.

What Is Amoxyclav 625?

Amoxyclav 625 is one of Abbott’s highest-selling antibiotic formulations in India, trusted by doctors and patients for decades. It is a combination of Amoxicillin and Clavulanic Acid, used to treat a wide range of bacterial infections — including pneumonia, ear and sinus infections, urinary tract infections, and skin and soft tissue infections.

Given its widespread use and brand reputation, the discovery of counterfeit versions poses a serious risk not just to patients, but also to the credibility of India’s pharmaceutical ecosystem.

Abbott’s Safety Measures and Distributor Instructions

The communication from Abbott and Biomech Healthcare urged all distribution partners to verify their stocks and ensure purchases are made only through authorised stockists.

“To ensure product authenticity and patient safety, please make all purchases exclusively through our authorised stockists,” the alert stated.

Stockists and distributors have also been directed to “immediately notify” Abbott or Biomech Healthcare if they come across any of the suspicious batches, and to cooperate fully in preventing further circulation of counterfeit stock.

The message further added that this advisory serves as a critical alert to safeguard the integrity of Abbott’s products and the well-being of patients, urging all partners for “prompt attention and responsible action.”

Rising Concern Over Counterfeit Drugs in India

This is not an isolated incident. India has been facing repeated cases of counterfeit and substandard drugs being detected in the market — particularly antibiotics, anti-malarials, and paediatric syrups.

In 2023 and early 2024, several global regulatory authorities, including the World Health Organization (WHO), raised alarms over Indian-manufactured cough syrups found to contain toxic contaminants in countries such as Gambia, Uzbekistan, and Cameroon.

According to WHO estimates, about 35% of fake drugs sold worldwide originate from India, reflecting the scale of the problem.

Experts say that while India is globally recognized as the “pharmacy of the world,” producing over 20% of the world’s generic medicines, it also faces challenges of weak enforcement, parallel supply chains, and inadequate verification systems in the domestic market.

The Economic and Ethical Impact

The presence of counterfeit medicines like fake Amoxyclav not only endangers patient lives but also undermines public trust in pharmaceutical brands and healthcare systems.

“Counterfeit antibiotics are especially dangerous because they may contain subtherapeutic doses or wrong ingredients,” said a senior pharmacologist on condition of anonymity. “This can lead to treatment failure and antimicrobial resistance — a silent pandemic already threatening global health.”

Moreover, counterfeit products eat into legitimate market share, causing financial losses for companies and tax revenue leakages for the government. The WHO estimates that counterfeit medicines cost the global economy over $30 billion annually.

Need for Stronger Regulation and Digital Verification

The incident has reignited discussions around the urgent need for robust track-and-trace mechanisms in India’s drug supply chain. The government has been pushing for implementation of barcoding and digital traceability under the Drug Authentication and Verification Application (DAVA) system and new QR code mandates by the Central Drugs Standard Control Organisation (CDSCO).

Once fully operational, such systems could help pharmacists and consumers instantly verify the authenticity of medicines using a mobile app or QR code scan.

However, experts argue that the system’s success will depend on widespread compliance by manufacturers, wholesalers, and retailers, as well as consumer awareness.

A Call for Vigilance

Abbott’s latest action serves as a reminder that even the most reputed multinational companies are not immune to counterfeiting threats in India’s vast and complex pharmaceutical landscape.

Healthcare professionals are being urged to check packaging carefully, verify batch numbers, and report any suspicious product variations — such as differences in colour, texture, or print quality — to the authorities.

Meanwhile, patients should purchase medicines only from licensed pharmacies, avoid online sellers without verified credentials, and check for manufacturing and expiry details on every strip.

Conclusion

The detection of counterfeit Amoxyclav 625 highlights the growing need for joint accountability between pharma companies, regulators, and the healthcare supply chain. Abbott’s swift action and transparent communication reflect an encouraging step toward patient safety.

But experts say the problem runs deeper — requiring systemic reforms, technology-driven traceability, and strict enforcement to ensure that the medicines reaching Indian households are 100% genuine.

Until then, the call for vigilance continues — for companies, chemists, and consumers alike.

MDC Seeks SNCM, CDSCO Clarification on Midazolam Nasal Spray’s Inclusion in NLEM 2022

2025-10-06T03:23:00.000-07:00

The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA) on pricing issues, has sought official clarification from the Standing National Committee on Medicines (SNCM) and the Central Drugs Standard Control Organisation (CDSCO) regarding the inclusion of midazolam nasal spray in the National List of Essential Medicines (NLEM), 2022.

This move comes after Noida-based Biodeal Pharmaceuticals Ltd applied for exemption of its formulation — midazolam nasal spray 1.25 mg — from price control under Para 32(iii) of the Drugs Prices Control Order (DPCO), 2013. The company argued that its product represents a new drug delivery system developed through indigenous R&D, making it eligible for a five-year exemption from price regulation.

However, the situation became complex when CDSCO confirmed that it had granted new drug approval to Biodeal for the formulation on May 5, 2025, while also clarifying that no other strength of midazolam nasal spray had been approved so far. The MDC, on the other hand, observed that the formulation was already listed in NLEM 2022, suggesting that it should have been an already approved drug.

To resolve this discrepancy, the Committee has asked both SNCM—which oversees the revision of NLEM—and CDSCO to provide their views on the approval status and the inclusion process of the drug in the 2022 list.

According to records submitted by Biodeal, the Subject Expert Committee under CDSCO had earlier noted that while midazolam tablets and injection forms were previously approved, the intranasal route had not been authorized before Biodeal’s application—indicating that their formulation was indeed novel.

In August 2025, CDSCO reiterated its position that Biodeal’s midazolam nasal spray 1.25% w/v was the only approved formulation to date. A follow-up communication on September 11, 2025, confirmed this once again.

The MDC emphasized that as per NLEM 2022 criteria, any drug included in the list must already be approved and licensed in India. Moreover, NPPA has already fixed a ceiling price for midazolam nasal spray based on market data showing at least three companies manufacturing or marketing the formulation.

In its September 16, 2025, meeting, the Committee concluded that further clarity from both SNCM and CDSCO is essential before proceeding. Once their inputs are received, the matter will be reviewed again by the MDC.

Under Para 32(iii) of DPCO 2013, manufacturers introducing a new drug with a novel delivery system developed through indigenous research can seek exemption from price control for five years from the start of commercial marketing.

Novo Wins EU Regulatory Backing for Weekly Diabetes Drug Kyinsu

2025-09-19T04:47:00.000-07:00

Novo Nordisk A/S’s once-weekly diabetes drug was recommended for approval in the European Union, paving the way for patients to be able to access another option to control their condition.

The European Medicines Agency’s drug review panel recommended approval for Kyinsu in patients with type 2 diabetes. The combination injection of insulin and semaglutide — the active ingredient in Novo’s blockbuster drug Ozempic — is also known as IcoSema.

Trials of the drug show it can help patients with type 2 diabetes control their weight and low blood sugar more than daily injections of insulin. It can be helpful for patients who are unable to control their diabetes with daily insulin.

The long-acting insulin portion of the drug had previously been rejected by the US Food and Drug Administration, which asked for more detail on the manufacturing process and the type 1 diabetes indication.

Pharma Exports to grow at a faster, will touch $31 billion

2024-05-30T21:56:00.000-07:00

Pharmaceutical exports, a mainstay of India's trade, set to accelerate 11% in FY25 to record $31 B. Inherent strengths apart, driving the growth will be shortage of drugs in US. Catch all the details

India’s pharmaceutical exports are expected to grow over 11% and touch record $31 billion in FY25 on the back of multiple factors, especially a shortage of drugs in the key U.S. market, a top official of the exporters body under the Commerce Ministry said on Thursday.

For the fiscal ended March 2024, pharma exports, a mainstay in the country’s global trade, rose 9.6% to $27.8 billion. The growth came amid numerous global challenges, Pharmaceuticals Export Promotion Council of India Director General Ravi Uday Bhaskar said.

More than 50% of the exports last fiscal were to highly regulated markets such as North America and Europe. “Pharmaceutical exports to the U.S. increased 15% to more than $8 billion, while the exports to the U.K. were 21% higher at $783 million demonstrating the robust growth of the Indian pharmaceutical industry even in challenging situations,” he told Pharma Lytica expo and conference that got underway in Hyderabad.

As long as India continued to manufacture quality drugs at affordable prices the industry will remain unmatched, he said. Geo-political tensions, economic slowdown and logistical challenges apart, Indian pharma industry faced heat last fiscal over quality issues.

Talking to The Hindu, Mr. Bhaskar said the shortage of generic prescription drugs in the U.S. is expected to increase in the backdrop of some units there shutting down.

Likewise, the demand in shipments to Africa is expected to enhance as non governmental organisations that had shifted their focus to Covid had reverted to supply of free drugs.

Pharma exports to grow at a faster clip, touch $31 billion in FY25

Pharma exports to Africa, which had declined 5% in FY23, ended 8% higher last fiscal.

Barring CIS countries, pharma exports to all other markets were higher year on year in

FY24. As a pointer to the road ahead, the exports in April 2024 rose more than 7%

Counterfeit Medicines is Getting On The Right Track

2024-05-23T07:49:00.000-07:00

Counterfeit medicines remain a threat globally. The EU and the US already have track and trace systems in place, and other regions are following suit.

The growing number of governments using track and trace systems in the pharmaceutical industry is partly down to an increase in mandates originating from APAC nation governments. Many serialization solution vendors are now working to expand their geographical presence to other regions. We spoke to Advanco CEO Alf Goebel to find out why the APAC region is seeing considerable attention – and how else technology can change pharma’s future.

How big is the threat of counterfeit medicines in the online age?

The threat posed by counterfeit medicines has been present for many years. However, the internet, where drugs can be sold directly to consumers without the need for any physical premises, adds to this threat.

I want to be very clear. We are not criticizing regulated, legal online pharmacies. They provide a valuable service for many people and are now established as part of the fabric of the healthcare system in many geographies. However, the modus operandi does provide criminals with the means to distribute their goods in a manner that means they are much less likely to be traced.

It is worth reminding ourselves of the scale of the problem. Figures from the Pharmaceutical Security Institute show that 6,615 pharmaceutical crime incidents were reported in 2022, up 10 percent on the year before.

The greatest number was recorded in North America (3,029) followed by the Asia Pacific (1,738), Latin America (934), the Near East (825), Eurasia (650), Europe (278) and Africa (185). The order of this list is largely due to how well countries in these regions are effectively identifying pharmaceutical crime through law enforcement activity and inspections by drug regulatory agencies.

According to the World Health Organization, roughly 10 percent of medical products circulating in low- and middle-income countries are substandard or falsified. In sub-Saharan African nations, this share is believed to be even higher – rising up to 19–50 percent. However, the actual number of incidents of fake drugs being manufactured and distributed may be far higher, considering the many cases where counterfeits have not been detected or reported.

I think it is necessary to see the issue as a global one that affects everyone. To fight the overall problem, every country needs to work hard to deploy resources.

What is driving expansion in the APAC region?

Increasing demand for serialization solutions worldwide and the emergence of Singapore as a pharmaceutical research and development hub are important factors in their own right that influenced our decision to expand in the APAC region.

Governments across the world are understanding that track and trace is one of the most effective methods to provide a guarantee to consumers that a particular medicine is genuine. We are now seeing mandatory regulations evolving in APAC, with India, China, and South Korea already having them in place; Indonesia and Malaysia are expected very soon, and other countries are working on their strategies. In the middle of such major developments, a dedicated APAC-focused resource will enable us to serve the region much more closely.

What are the key challenges in implementing track and trace systems?

Some pharma serialization solutions are perhaps too complex – and also inflexible. Regulations change and you need to be able to accommodate those changes. As an example (and something that I argue against), many providers will install specific software that can only be used with their hardware. When this happens, the pharma company risks losing the ability to either expand or adapt its manufacturing capabilities because of vendor lock in. Furthermore, it results in ever-increasing costs because of the by-design inflexibility of the all-in-one vendor systems, as well as the ongoing upgrade costs.

The serialization sector needs to be far more transparent. If there were to be another pandemic, the pharma sector would face challenges that would demand the ability to identify and deploy the most appropriate action. In such a scenario, the ability for serialization and traceability solutions across the board to work together in unison would be a massive advantage. It would enable packaging serialization solutions to coordinate in warehouses and shop floors right across the globe. Such capability could potentially save millions of lives in an emergency.

The COVID-19 pandemic saw the rapid design and roll-out of an entirely new pharmaceutical cold chain capable of preparing, shipping, and storing vaccines in temperatures as low as minus 80 degrees. This was done through collaboration – and we need to ensure that collaboration of this kind continues, so that we can be prepared for the next pandemic.

How else can new technologies help shape the future of the industry?

Health itself is becoming increasingly digital. Think of all the opportunities in healthcare, from telehealth solutions to wearable devices. There are a whole raft of personal medicine applications to manage the patient treatment lifecycle at an individual level.

For pharmaceutical manufacturers, technology can help increase the efficiency of systems, products, and services. The cloud, for example, has rewritten the way computing works, allowing firms to power their system and retain full records without a single server on site. Computing and automation is also being used to reduce the risk of human error. In the future, I expect robotics to become much more affordable and available to organizations of every size. From picking products at a warehouse to getting them ready to ship, autonomous robots can quickly and safely support manufacturers. Likewise, we will see distribution centers that will use autonomous cranes and trucks to streamline operations as they accept shipping containers.

Nicaragua becomes first Spanish-speaking nation to recognize Indian Pharmacopoeia

2024-02-29T03:17:00.000-08:00

In a significant diplomatic development, Nicaragua has become the first Spanish-speaking nation to officially recognize the Indian Pharmacopoeia (IP) or Indian Pharma standards. This development follows the signing of a Memorandum of Understanding (MoU) on Pharmacopoeia Cooperation between the governments of India and Nicaragua.

The ceremony, held in Nicaragua's capital, saw the signing of the MoU by Dr Sumit Seth, the Indian Ambassador to Nicaragua, and Dr Martha Reyes, Nicaragua's Minister of Health.

The Memorandum of Understanding underscores a shared commitment to collaboration in the regulation of medicines, marking a crucial step towards international harmonization of pharmaceutical standards.

The move is expected to foster stronger ties between the two nations in the areas of healthcare, encouraging the exchange of expertise and resources for improved medical standards.

The Indian Pharmacopoeia (IP), compiled by the Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare in India, serves as the official compendium of standards for drugs.

With the latest edition published in 2022, the IP comprises over 3,000 monographs, establishing precise limits and testing methods for both raw materials and finished pharmaceutical products.

The legal significance of the IP within India, enshrined in the Second Schedule of the Drugs & Cosmetics Act, 1940, necessitates adherence to its standards for all imported, manufactured, and distributed drugs within the country.

This recognition by Nicaragua adds another feather to the IP's cap, solidifying its global standing and influence.

The IPC, an autonomous institute with the mandate to publish the IP at regular intervals has created a key document as a benchmark for pharmaceutical standards.

The IP's recognition by Nicaragua follows suit with five other countries - Afghanistan, Ghana, Nepal, Mauritius, and Suriname - who have already acknowledged its importance in ensuring the quality and safety of medicinal products.

The formal recognition of the Indian Pharmacopoeia serves as a testament to the growing importance of standardized regulations in the global pharmaceutical landscape.

UP Released Pharma & Medical Devices Industry Policy, 2023

2023-08-06T22:37:00.002-07:00

The Uttar Pradesh government has issued the Pharmaceutical and Medical Devices Industry Policy, 2023, which includes provisions for a single window clearance under the direct supervision of the Chief Minister's office, time-bound clearances, pre-consultation of project plans by the regulator, and a dedicated technical advisory body for guidance and support, in addition to incentives for pharma parks, manufacturing units, and support for start-ups and marketing activities.

The State will have a single window clearance system, which will be directly supervised by the Chief Minister's office, as part of its efforts to promote ease of doing business.

The regulations will ensure timely delivery of services, clearances, permissions, and permits as part of making time bound clearances.

The Food and Drug Administration (FSDA) will appoint a nodal officer to help investors in obtaining the pollution No Objection Certificate (NOC) and other certificates required to develop pharmaceutical facilities.

The FSDA team will review the project dossier and building plan supplied by the investors to determine the feasibility of the project, and a Letter of Comfort will be issued to the investor following satisfactory scrutiny of the dossier.

The government will also set up the Uttar Pradesh Pharmaceutical Development Cell (UPPDC) as an advisory body for technical guidance and support.

The cell will be chaired by the Additional Chief Secretary or Principal Secretary of the Department of FSDA and consist of representatives from concerned departments and experts from different areas of pharmaceutical and biotechnology, while representatives from the industry associations will be invited members. The matter referred by the regulatory committees and others will be taken up by the Cell from time to time and it will also facilitate the development of a data bank and resource centres apart from other supports.

There will also be an Empowered Committee, chaired by the Chief Secretary, to oversee the policy's development and the scheme's implementation. It would also have the jurisdiction to approve proposals for mega projects (projects with a capital investment of more than Rs. 100 crore). Representatives from industry associations will also be invited members.

The policy aims to revamp the State's pharmaceutical and medical device industry by encouraging local production, promoting research and development and improving the availability of affordable medicines to the citizens.

The policy focuses on creating a conducive environment for the growth of the pharmaceutical industry in the state aiming to attract investments in the sector by providing a range of incentives such as subsidies and land allocation for setting up manufacturing units.

It also intends to create a robust ecosystem for research and development by setting up State-of-the-art facilities and collaborating with academic institutions and research institutes.

Around 217 companies have proposed to invest nearly Rs. 28,500 crore in the pharmaceutical and medical devices sector. These investments are expected to create nearly 57,000 job opportunities, boost the local economy, and contribute to the growth of the sector. The State also has a robust manpower availability for the industry, it added.

CDSCO Suspended Manufacturing of Eye Drops of Global Pharma, Chennai

2023-02-04T02:55:00.004-08:00

India's Central Drugs Standard Control Organization (CDSCO) has suspended the manufacturing of eye drops at the Chennai-based firm after US FDA allegedly linked 55 adverse events cases with contaminated eye drops.

The samples were taken for analysis from four batches of control samples. The sample of raw material Carboxy Methyl Cellulose Sodium was also taken: Sources on 'Artificial Tears' eyedrops

The manufacturer was instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of the investigation

During the investigation by senior drug inspectors, it was found that Chennai-based firm Global Health Care Pvt Ltd had exported two consignments of 24 batches of 'Artificial Tears' to USA which were manufactured in 2021 and 2022

Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears.

6 months jail if TDS on Free Samples to Doctors not Deposited

2023-02-02T19:48:00.004-08:00

The Union Government has recently clarified that failing to deduct and pay 10 percent TDS on the value of freebies received by doctors, as required under Section 194R (TDS on benefit or perquisite in respect of business or profession) in the Income-tax Act, 1961, will attract jail term for up to 6 months and a sum of penalty.

This came during the budget for the year 2023-24, wherein, various amendments have been proposed for the taxpayers by the Union Finance Minister Nirmala Sitharaman.

Last year, the Central Board of Direct Taxes (CBDT) had issued the guidelines clarifying the applicability of the newly inserted section 194R in the Income-tax Act, 1961 effective July 1, 2022.

The new section 194R mandates a person, who is responsible for providing any benefit or perquisite to a resident, to deduct tax at source @ 10% of the value or aggregate of value of such benefit or perquisite, before providing such benefit or perquisite. The benefit or perquisite may or may not be convertible into money but should arise either from carrying out of business, or from exercising a profession, by such resident.

However, the provisions for penalty and prosecution did not clearly mandated penalty or prosecution for a person who does not pay or fails to ensure compliance to the said Section.

To ensure highest level of compliance and adherence to Section 194R, lately, the Government has proposed to amend section 271C and section 276B of the Act by incorporating penalty and prosecution provisions pursuant to non-adherence of Section 194R (TDS on benefit or perquisite in respect of business or profession) effective from the 1st day of April, 2023.

With this, all Assessess need to be vigilant and cannot take these provisions lightly.

Section 271C is proposed to be amended to state that where a person fails to pay or ensure payment as required under Section 194R, then Section 271C which is a penalty provision, can get attracted.

Further, Section 276B refers to prosecution and corresponding amendments for non-compliance of Section 194R and Section 194S have been proposed in prosecution provisions as well.

After section 276A of the Income-tax Act, the following section shall be inserted, namely: —

"276B. If a person, without reasonable cause or excuse, fails to deduct or after deducting fails to pay the tax as required by or under the provisions of sub-section (9) of section 80E or Chapter XVII-B, he shall be punishable with rigorous imprisonment for a term which may extend to six months, and shall also be liable to fine which shall be not less than a sum calculated at the rate of fifteen per cent, per annum on the amount of such tax from the date on which such tax was deductible to the date on which such tax is actually paid."

The move is going to cast a severe dent on the traditional pharma marketing practices across the country. The applicability of the new provision is likely to make handing out of freebies and even free samples to doctors less attractive, which comes as a major setback for pharma companies.

Medical Dialogues team had earlier reported that the new Finance Budget had clarified that any claims of expenses incurred while providing benefits to others that violate the provisions of Indian Medical Council Regulations, 2002 shall be inadmissible for a tax deduction. With this, pharma companies can no longer claim such expenditure as a business deduction, which in turn will jack up the taxable profits of a pharma company. The Government has also been considering to make the UCPMP mandatory for all pharmaceutical companies.

Zero observations of USFDA for Gland Pharma's Visakhapatnam facility

2023-01-30T19:41:00.003-08:00

Gland Pharma said that the United States Food and Drug Administration (US FDA) had conducted an inspection at the company's API Facility at JNPC, Visakhapatnam, from 23rd January 2023 to 27th January 2023.

The drug maker further informed that the said inspection has been completed with 'zero' observations.

Hyderabad-based Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.

The pharmaceutical company's consolidated net profit dropped 15% to Rs 231.95 crore on 11.8% decline in net sales to Rs 938.29 crore in Q3 FY23 over Q3 FY22.

The scrip had advanced 1.16% to end at Rs 1357.10 on the BSE on Friday.

Labeling Norms For Generic Drugs Changed: Health Minister

2018-03-12T02:25:00.001-07:00

The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey through a written reply in the Lok Sabha informed about the labeling norms for generic drugs.

In order to ensure that the consumer is well informed about the generic medicine, Ministry of Health and Family Welfare published a draft notification for public comments vide GSR 302 (E) dated 30.03.2017 for amendment of Rule 96 to provide that the proper name of the drugs shall be printed in a conspicuous manner which shall be in the same font but at level two font size larger than the brand name or the trade name, if any. It will come to force after completion of due formalities as per the provisions of the Drugs and Cosmetics Act, 1940.

Indian Drug Manufacturers Association (IDMA) was invited to the stakeholders meeting held on 12.12.2017 in Central Drugs Standard Control Organisation (CDSCO) and they conveyed their inability to attend the meeting. However, they had already provided their suggestions/ comments on the draft notification vide letter dated, 11.05.2017 which has been received in the Ministry.

#Natco Pharma seeks #USFDA Approval for #Hepatitis Drug

2018-03-05T02:36:00.000-08:00

Drug firm Natco Pharma said it has filed an abbreviated new drug application (ANDA) for Sofosbuvir Tablets, 400mg, with the United States Food and Drug Administration (USFDA).

Sofosbuvir is used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc, under its brand Sovaldi, Natco Pharma said in a filing to BSE.

The company believes that “they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval,” it added.

For the 12 months ending December 31, 2017, Sovaldi had US sales of approximately USD 130 million as per Gilead Sciences Inc’s unaudited results released for the year ending December 31, 2017, Natco Pharma said.

Applications for r-DNA derived Drugs via #Sugam Portal Now

2018-01-23T02:33:00.000-08:00

Through a recent notification, CDSCO has said that the filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be initiated with effect from 01.02.2018 in SUGAM portal

The authority has decided that applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be accepted through online mode only from 1st Feb 2018 and no offline applications will be accepted after that.

On November 14, 2015, the Central Drugs Standard Control Organisation has launched an online portal SUGAM (www.cdscoonline.gov.in) in pursuance of the implementation of E-Governance.

The notice states that a reference is also invited to the stakeholders meeting held on 10.01.2018 wherein it has been agreed upon that, filling of application for Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs will be initiated with effect from 01.02.2018 in SUGAM portal.

In view of above, it has been decided that applications pertaining to Clinical Trial, Marketing Authorization, Registration Certificate and Import License for r-DNA Derived Drugs shall be accepted only through online mode from 1st Feb 2018 and no offline applications will be accepted thereafter.

Download Notification

#NPPA Sets aside notification on Fixation of #Erythromycin Price

2018-01-19T21:09:00.002-08:00

Through a recent notification, National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India has set aside its notification of dated 11th May 2017 in which the regulator had fixed the ceiling price of the following formulations with immediate effect.

1. Erythromycin Estolate Tablet 250mg

2. Erythromycin Estolate Tablet 500mg

3. Erythromycin Estolate Syrup 125 mg / 5 ml

4. Chloroquine Phosphate Injection 40 mg / ml (64.5mg eq. to 40mg chloroquine)

On 11th May 2017, NPPA had fixed the prices of the Erythromycin Estolate Tablet 250mg at Rs 3.02 for 1 tablet, Erythromycin Estolate Tablet 500mg at Rs 5.86 for 1 tablet, Erythromycin Estolate Syrup 125 mg/5 ml at Rs 0.53 for 1ml, and Chloroquine Phosphate Injection 40 mg / ml (64.5mg eq. to 40mg chloroquine) at Rs 1.31 for 1ml.

However, challenging the said notification, Alembic Pharmaceuticals Limited filed a petition under paragraph 31 of the Drugs (Prices Control) Order, 2013

The petitioner contended that Erythromycin formulations namely Erythromycin Tablet 500mg, Erythromycin, Tablet 250mg and Erythromycin Syrup 125mg/5ml have been shifted to Non scheduled by the Government on 10th March 2016 and NPPA has been directed to regulate the Scheduled drugs shifted to Nonscheduled category as NON-SCHEDULED drugs under para 20 of DPCO, 2013.

Furthermore, the petitioner contended that NPPA had fixed the ceiling prices of above said Non-scheduled formulations referring to the paras 4,10,11,14,16,17 and 18 of DPCO, 2013, which is inconsistent with provisions of DPCO, 2013.

After examination government had directed NPPA to issue revised SO within one month by excluding the formulations Erythromycin Estolate Tablets 250mg, Erythromycin Tablets 500mg and Erythromycin Syrup 125mg.5ml., which have since been shifted to non-scheduled category under Schedule-I of NLEM, 2015, and re-fixing the ceiling price of only one formulation, viz. Chloroquine Phosphate Injection 40mg/ml.

Following the notification of the government, NPPA re-examined and submitted the report to the government after that DoP stated that

“NPPA is hereby directed to set aside the SO 1526(E), dated 11.5.2017, as all the four formulations, i.e. Erythromycin Estolate Tablets 250 mg, Erythromycin Estolate 500mg, Erythromycin Estolate Syrup 125mg/5ml and Chloroquine Injection 40mg/ml, have been shifted to non-scheduled category vide SO 701(E), dated 10.3.2016.”

Below is the attachment for the same.

http://www.nppaindia.nic.in/ceiling/press16jan18/Price_Order.pdf

Voveran 1ml causes Kidney Damage: Health Ministry Recommends Toxicity Check

2018-01-05T21:15:00.000-08:00

Diclofenac injection is a painkiller which is manufactured by Themis Medicare Ltd and marketed by Novartis India under the brand name Voveran 1 ml Injection.

Troikaa Pharmaceuticals had alleged that the painkiller injection diclofenac Sodium 75 mg/ml contains Transcutol, which damages kidneys and filed a petition in Delhi High Court against the granting of manufacturing licenses for the painkiller and allowing its marketing by Novartis AG.

Troikaa has developed and sells Diclofenac Sodium 75 mg/ml injection under the brand name ‘Dynapar AQ’, which is patented globally.

The petition stated that Themis to avoid patent infringement, is manufacturing a different version of its Diclofenac Sodium 75 mg/ml injection and Novartis is marketing it.

The petition further stated that Themis and Novartis have conveniently ignored the fact that Transcutol P is not recommended for parenteral use Regulatory bodies in US, Europe, and other parts of the world do not permit it’s parenteral use, as it is known to cause injury to kidneys.

During the hearing, the court had formed an expert panel to review the safety of Transcutol-P who gave their recommendations in favor of Troikaa. Novartis then approached the health ministry after which the second panel was formed under the Directorate General of Health Services. The second panel gave their decision in favor of Novartis.

Another panel was formed under Girish Sahni, director general, Centre of Scientific and Industrial Research (CSIR), in May after the contradictory reports on Troikaa’s allegations.

The which submitted its report on 29 December, endorsed Troikaa’s submissions. The committee also did not find any evidence supporting the claim of Novartis and Themis, two people aware of the matter said, adding that the panel has recommended that Transcutol-P be independently tested for toxicity.

Sahni panel, A spokesperson for Themis maintained that product is absolutely safe and told , “Post our meeting with the committee sometime in July 2017, we do not have any further status on the subject from authorities, hence unable to comment.”

#USFDA Warning Letter to German Drug Firm for Baddi Plant

2018-01-05T00:02:00.002-08:00

US health regulator USFDA has issued a warning letter to German drug firm Fresenius Kabi AG for

lapses at its drug manufacturing facility at Baddi in Himachal Pradesh.

In a letter to the company’s CEO Mats Henriksson summarising violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, United States Food and Drug Administration (USFDA) said it had conducted inspection of the Baddi facility from April 6 to 14, 2017.

“Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed,” the health regulator said.

While saying that it had reviewed company’s May 10, 2017, response in detail and acknowledges receipt of its subsequent correspondence, USFDA asked the drug firm to provide plans and procedures to ensure that future sterility failure investigations included a more thorough review of long-term trends.

The regulator also asked Fresenius Kabi AG to ensure sufficient investigation of potential vulnerabilities in the manufacturing operation and potential correlations with past incidents.

The letter also said that in an inspection from May 14 to 22, 2015, FDA had cited a similar CGMP observation in which the company invalidated sterility test failures without adequately investigating the root causes, and failed to take timely and appropriate corrective actions.

“Although you proposed remediations in your responses following the 2015 inspection, and discussed these plans during a 2016 regulatory meeting with the Agency, our current inspection found that your facility’s oversight and control over the manufacture of drugs remains deficient,” it added.

Recommending engaging of CGMP Consultant, USFDA said based upon the nature of the violations it strongly recommended engaging a consultant to assist the company in meeting CGMP requirements.

The regulator said until the company corrects all violations completely and “we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.”

Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Fresenius Kabi Oncology at Baddi in the United States, USFDA said.

51 Essential Drugs under #NPPA Price cap,check out details

2017-11-25T03:09:00.000-08:00

National drug pricing regulator NPPA on Friday said it has capped prices of 51 essential formulations, including those used for the treatment of cancer, pain, heart conditions and skin problems.

The prices have been slashed in the range of 6 to 53 percent.

In separate notifications, the drug price regulator said it has notified ceiling prices of 13 formulations while revising the same for 15 formulations.

Moreover, retail prices of 23 essential formulations have also been notified, National Pharmaceutical Pricing Authority (NPPA) said.

Drugs whose ceiling prices have been capped includes colon or rectal cancer treatment drug oxaliplatin (injection 100mg), Japanese encephalitis vaccine and measles rubbela vaccine.

On the other hand, ceiling prices of drugs including anesthetic sevoflurane, Phytomenadione (Vitamin K1) and tuberculosis prevention medicine BCG vaccine have been revised.

According to highly placed sources in NPPA, the reduction in prices following the latest exercise will range between 6- 53 percent.

NPPA fixes ceiling price of essential medicines of Schedule I under the Drugs (Prices Control) Order (DPCO) 2013.

In respect of medicines that are not under price control, manufacturers are allowed to increase the maximum retail price by 10 percent annually.

The calculation of essential drugs is based on the simple average of all medicines in a particular therapeutic segment with sales of more than 1 percent.

Set up in 1997, NPPA has been entrusted with the task of fixation/revision of prices of pharma products, enforcement of provisions of DPCO and monitoring of prices of controlled and decontrolled drugs.

Following are the details:

Sl. No.	Name of the Scheduled Formulation	Dosage form & Strength	Unit	Ceiling Price (Rs.)
(1)	(2)	(3)	(4)	(5)
1.	Oxaliplatin	Injection 100mg (as licensed)	Each Pack	4055.10
2.	Acetylsalicylic acid	Effervescent/ Dispersible/ Enteric coated Tablet 100 mg	1 Tablet	0.1625
3.	Japanese Encephalitis Vaccine	4mcg to 6mcg	Each Pack	632.95
4.	Japanese Encephalitis Vaccine	up to 3mcg	Each Pack	482.22
5.	Measles Rubbela Vaccine		Each Pack (0.5ml)	80.22
6.	Surfactant	Suspension for intratracheal instillation (As liensed)	Per mg of Phospholipids in the pack	60.69
7.	Sevoflurane	Inhalation	1 ml	24.12
8.	Acetylsalicylic acid	Tablet 325mg	1 Tablet	0.50
9.	Desferrioxamine	Powder for Injection 500mg	Each pack	145.91
10.	Oxaliplatin	Injection 50mg (as licensed)	Each Pack	2303.01
11.	Phytomenadione (Vitamin K1)	Injection 10mg/ml	1 ML	43.45
12.	Glutaraldehyde	Solution 2%	1 ML	0.05868
13.	Anti-D immunoglobulin	Injection 300mcg	Each Pack	1936.82
14.	BCG vaccine		Each Dose	4.32
15.	Morphine	SR Tablet 30 mg	1 Tablet	4.94
16	Alteplase	Powder for Injection 20 mg	Each Pack	17235.00
17.	Alteplase	Powder for Injection 50 mg	Each Pack	35985.00
18.	Gadobenate	Injection 529 mg/ml	1 ML	98.90
19.	Haemodialysis fluid	As license	1 ML	0.03695
20.	Furosemide	Oral liquid 10 mg/ml	1 ML	0.29
21.	Glucose	Injection 50%	1 ml	0.44
22.	Lignocaine (A) + Adrenaline (B)	Injection 1% (A) + 1:200000 (5 mcg/ml) (B)	1 ML	0.41
23.	Calcium gluconate	Injection 100 mg/ml	1 ML	0.50
24.	Dextran-40	Injection 10%	1 ML	0.38
25.	Coagulation factor IX	Powder for Injection 600 IU	Each Pack	11,180.00
26.	Digoxin	Oral liquid 0.05 mg/ml	1 ML	0.29
27.	Potassium permanganate	Crystals for topical solution	1 gm	0.40
28.	Pilocarpine	Drops 4%	1 ML	10.60

Sl. No.	Name of the Scheduled Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
1.	Sofosbuvir & Velpatasvir	Each film coated tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg	28 Tablets	M/s Hetero Labs Ltd. / M/s Abbott India Ltd.	15625.00
2.	Sofosbuvir & Velpatasvir	Each film coated tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg	28 Tablets	M/s Hetero Labs Ltd. / M/s Cadila Healthcare Ltd.	15625.00
3.	Sofosbuvir & Velpatasvir	Each film coated tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg	28 Tablets	M/s Natco Pharma Ltd. /M/s Sun Pharmaceuticals Industries Ltd.	15625.00
4.	Sofosbuvir & Velpatasvir	Each film coated tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg	28 Tablets	M/s Natco Pharma Ltd. / M/s Cipla Ltd.	15625.00
5.	Sofosbuvir & Velpatasvir	Each film coated tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg	28 Tablets	M/s Natco Pharma Ltd.	15625.00
6.	Sofosbuvir & Velpatasvir	Each film coated tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg	28 Tablets	M/s Natco Pharma Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd	15625.00
7.	Sofosbuvir & Velpatasvir	Each tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg	28 Tablets	M/s Dr. Reddy’s Limited	15,625.00
8	Sofosbuvir & Velpatasvir	Each tablet contains: Sofosbuvir 400mg, Velpatasvir 100mg	28 Tablets	M/s Hetro Labs Ltd.	15,625.00
9.	Voglibose + Metformin	Each tablet contains: Voglibose 0.2mg, Metformin 500mg	1 Tablet	M/s Lupin Ltd.	4.84
10.	Voglibose + Metformin	Each tablet contains: Voglibose 0.3mg, Metformin 500mg	1 Tablet	M/s Lupin Ltd.	5.76
11.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 1mg	1 Tablet	M/s Lupin Ltd.	7.14
12.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 1mg	1 Tablet	M/s Sanofi India Ltd.	7.14
13.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 1mg	1 Tablet	M/s Biocon Ltd.	7.14
14.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 2mg	1 Tablet	M/s Lupin Ltd.	9.05
15.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.2mg, Metformin 500mg, Glimepirid 2mg	1 Tablet	M/s Sanofi India Ltd.	9.05
16.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.2mg Metformin 500mg Glimepirid 2mg	1 Tablet	M/s Biocon Ltd.	9.05
17.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.3mg, Metformin 500mg, Glimepirid 1mg	1 Tablet	M/s Lupin Ltd.	8.52
18.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.3mg, Metformin 500mg, Glimepirid 1mg	1 Tablet	M/s Alembic Ltd.	8.52
19.	Voglibose + Metformin + Glimepirid	Each tablet contains: Voglibose 0.3mg, Metformin 500mg, Glimepirid 2mg	1 Tablet	M/s Lupin Ltd.	10.46
20.	Diclofenac + Tramadol	Each tablet contains: Diclofenac 75mg, Tramadol 50mg	1 Tablet	M/s Alembic Ltd.	9.73

Sl. No .	Name of the Scheduled Formulation	Dosage form & Strength	Unit	Ceili ng Price (Rs.)	Review Order number and date	Existing SO number and date	Manufacturer & Marketing Company respectively
(1)	(2)	(3)	(4)	(5)	(6)	(7)	(8)
1.	Trypsin, Bromelain, Rutoside Trihydrate, & Diclofenac Sodium (Volitra Enzo) tablet	Each enteric coated tablet contains: Trypsin 48mg, Bromelain 90mg, Rutoside Trihydrate 100mg, Diclofenac Sodium 50mg	1 Tablet	13.91	31015/09/2017 -Pricing dated 27.08.2017	4131(E) dated 22.12.2016(at Sl. No. 5)	M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Sun Pharmaceuticals Ind. Ltd.

Sl. No.	Name of the Scheduled Formulation	Dosage form & Strength	Unit	Ceilin g Price (Rs.)	Review Order number and date	Existing SO number and date
(1)	(2)	(3)	(4)	(5)	(6)	(7)
1.	Ceftriaxone	Powder for Injection 1gm	Each Pack	48.92	31015/59/2017-Pricing dated 10.10.2017	2058(E) dated 30.6.2017 (at Sl. No. 120)
2.	Chloroquine	Tablet 150mg	1 Tablet	0.72	31015/32/2017- Pricing dated 24.8.2017	2059(E) dated 30.6.2017 (at Sl. No. 23)

Below are the attachments for the same.

http://www.nppaindia.nic.in/ceiling/press23oct17/Prices(1).pdf

http://www.nppaindia.nic.in/ceiling/press23oct17/Prices(2).pdf

http://www.nppaindia.nic.in/ceiling/press23oct17/Prices(3).pdf

http://www.nppaindia.nic.in/ceiling/press23oct17/Prices(4).pdf

http://www.nppaindia.nic.in/ceiling/press23oct17/Prices(5).pdf

http://www.nppaindia.nic.in/ceiling/press23oct17/Prices(6).pdf

http://www.nppaindia.nic.in/ceiling/press23oct17/Prices(7).pdf

#CDSCO Allows Relabeling of Old Medicines with Revised MRPs

2017-07-12T22:09:00.000-07:00

Through a recent notice, Directorate of General of Health Services, Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare has clarified that pharmaceutical companies can relabel old stocks of their medicines with the revised Maximum Retail Prices (MRP) applicable following implementation of the Goods and Service Tax (GST) regime.

The notice implied that on receipt of representation received from FICCI dated 7.7.2017 on the subject Stickering of Pharmaceuticals as per Act and Rules relating to Goods & Service Tax (GST),this office has no objection for alteration of label (stickering) by the manufacturers under rule 104A of the Drugs and Cosmetics Rules, 1945, if required for implementation of GST subject to provisions of Legal Metrology Act & Rules and other provisions of Act and Rules relating to Goods & Service Tax.

In a circular last week the Ministry of Consumer Affairs, Food and Public Distribution had already stated that manufacturers, packers and importers of pre-packaged commodities should declare the post GST MRPs of unsold stocks which were manufactured, imported or packed before July 1.

There had been lot of confusion among chemist regarding selling price of medicine till now and they had been selling old stocks of medicines at their pre-GST MRPs even after implementation of GST on 1st July. Incidentally pharma companies were expected to declare the new MRPs on the batches they manufactured after July 1. Attached below are relevant notifications concerning the issue.

CDSCO Notice GST :

Impact of GST on Unsold Stock of Pre-packaged Commodities:

15 Medical Devices Notified as Drugs for Price Regulation: #CDSCO

2017-07-07T00:41:00.001-07:00

Through a recent notice, Central Drugs Standard Control Organisation (CDSCO),Directorate General of Health Services, Office of Drugs Controller General India has informed about 15 notified medical devices classifying as drugs bringing them automatically under price regulation.

On a notice dated June 29, 2017, CDSCO stated that The Drugs & Cosmetics Act, 1940 is an Act to regulate import, manufacture,distribution and sale of drugs and cosmetics. It extends to the whole of India. Further, the Drugs & Cosmetics Rules, 1945 have been put in place which are updated from time to time for uniform implementation of the statutory requirements

The devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central govt by notification in official gazette, after consultation with the Board, fall under the definition of drug.

The list of devices, so far are appended includes:

1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. In vitro Diagnostic Devices for HIV, HbsAg and HCV
5. Cardiac Stents
6. Drug Eluting Stents
7. Catheters
8. Intra Ocular Lenses
9. I.V. Cannulae
10. Bone Cements
11. Heart Valves
12. Scalp Vein Set
13. Orthopedic Implants
14. Internal Prosthetic Replacements
15. Ablation Device

The notice further informed that the health ministry has notified Medical Devices Rules, 2017, to bringing critical medical devices like stents, orthopaedic implants and diagnostic equipment under stringent regulation,which will come into force with effect from 1st day of January, 2018.

Criteria for Classification of medical devices including in vitro diagnostics have been specified in Rule 4, Chapter II of the rules which deals with regulation of Medical Devices in Indian context and in line with International Classification.

“It is expected that the importers, manufacturers, distributors and supply chain personnel shall voluntarily adhere with the safety, performance and quality aspects as stated in the said medical devices Rule, 2017 for creating proper eco-system for its effective regulation.In order to facilitate the process a special cell has also been created consisting of concerned JDC (I), DDC (I) and ADC (I) to address the issues, if any.” the notice added

A draft list of Medical Devices and in vitro diagnostics along with their risk based classification is annexed. Attached is the notification regarding the same.

Download Here

Check out #NPPA new Mobile app to verify Costs of Medicines

2017-07-04T22:22:00.003-07:00

Public will now be able to track the information regarding their medicines they have been prescribed, their availability and prices through a new application on their smart phones. A new application known as ‘Pharma Sahi Daam’ has been introduced by NPPA that will help consumers to know the prices of scheduled medicines and non-scheduled medicines which are under price regulation after the implementation of the Goods and Services Tax (GST).

‘Pharma Sahi Daam’ is an online search tool which will indicate the MRP of the medicines (inclusive of VAT). This app will facilitate consumers to verify whether medicines are being sold within the approved price range and also to detect any case of overpricing by pharmaceutical company/chemist.

The app, developed by NPPA, provides information on the prices of scheduled medicines that are under price regulation as well as non-scheduled medicines. It also provides information about the nearest chemists and has a list of Jan-Aushadhi stores nearby

Apart from tracking the percentage of change in the cost of medicines, people can also register a complaint in case of overcharging of medicines on PHARMA JAN SAMADHAN website. (http://nppaindia.nic.in/redressal.html).

Helpline number: 1800111255

Whatsapp number; 9695736333

To download the app click on the link given below.

https://play.google.com/store/apps/details?id=com.nic.app.searchmedicineprice

#NPPA fixes ceiling prices of 814 scheduled Formulations

2017-07-04T02:26:00.001-07:00

New ceiling prices of 814 scheduled formulations became effective from today with drug pricing regulator NPPA fixing the cap in sync with the new GST regime. These formulations include medicines used for treatment of cancer, HIV, diabetes and infections among others. In a notification, National Pharmaceutical Pricing Authority (NPPA) said the fixation, revision of the prices of 814 scheduled formulations were done under Schedule-I under Drugs (Price Control) Amendment Order, 2016 under DPCO, 2013.

Union Chemicals and Fertilisers Minister Ananth Kumar had said yesterday that NPPA will work out a mechanism ensuring patients do not pay more for drugs whose prices are expected to go up after the GST implementation. NPPA has already said that prices of around 78 per cent of ‘actively used’ drugs will remain unaffected after the rollout of the Goods and Services Tax (GST), which took effect today. “Price of drugs where partial increase is expected due to roll out of GST will not be passed on to consumers as NPPA is working out a mechanism in this regard,” Kumar had told reporters. He had further stated NPPA is working out a mechanism “to subsume for partial increase of retail prices of some drugs”. Kumar reiterated that “prices of life saving drugs and essential drugs rates will come down with reduction in GST rate”. The regulator had earlier indicated that the prices of majority of essential drugs would increase by up to 2.29 per cent when the GST regime kicks in.

The government has fixed GST rate of 12 per cent on most of the essential drugs as against the earlier tax incidence of around 9 per cent. To check out the list of fix prices schedule formulations click on the following links

http://www.nppaindia.nic.in/ceiling/press30June17/so27042017e81-30-06-17_1.pdf http://www.nppaindia.nic.in/ceiling/press30June17/01so27042017e2-30-06-17_2.pdf http://www.nppaindia.nic.in/ceiling/press30June17/01so27042017e2-30-06-17_3.pdf

http://www.nppaindia.nic.in/ceiling/press30June17/01so27042017e2-30-06-17_4.pdf http://www.nppaindia.nic.in/ceiling/press30June17/01so27042017e2-30-06-17_5.pdf http://www.nppaindia.nic.in/ceiling/press30June17/01so27042017e2-30-06-17_6.pdf

Before #GST, #NPPA Releases Ceiling Price of 761 Medicines

2017-06-29T22:48:00.003-07:00

Drug price regulator NPPA on Tuesday announced provisional ceiling prices of 761 medicines, including anti-cancer, HIV, diabetes and antibiotic, with a majority being reduced ahead of the GST implementation. The National Pharmaceutical Pricing Authority (NPPA) said however that the actual increase or decrease in prices after the roll out of new indirect tax regime is expected to be in be in the range of 2-3 per cent depending on states. “In order to facilitate smooth implementation of GST

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