Generic Medicines

From expiry dates to red lines and dosage codes, medicine labels hold vital clues that can prevent overdosing, mix-ups, and dangerous errors

A Parliamentary panel has flagged that a substantial segment of cancer drugs are still beyond the ambit of current price control mechanisms and recommended measures to include the widest possible range of cancer drugs by expanding the scope of the Drugs Prices Control Order. In its 163rd report presented on Wednesday, the Committee on Petitions, Rajya Sabha, headed by Narain Dass Gupta stressed that regular and comprehensive market assessments should be instituted to monitor prevailing drug prices and availability trends. Though significant steps have been taken in recent years towards strengthening the regulatory framework for governing the pricing of cancer drugs and promote affordability, a substantial segment of such drugs still remain beyond the ambit of current price control mechanisms, it said. The Committee noted that with the notification of NLEM, 2022, the number of anti-cancer medicines under price control has increased from 40 (in 2011) to 63 (in 2022). However, a ...

Are cheaper generic medicines really as good as expensive branded ones? Here's what doctors and pharma experts say about quality, safety, and trust

The SC's suggestion to mandate generic-only prescriptions has drawn mixed reactions from the medical and pharma community, highlighting concerns over quality and feasibility

The Supreme Court has said doctors should prescribe only generic drugs. The court made the remark while hearing a PIL seeking tighter regulation of pharmaceutical marketing practices

Biocon Chairperson Kiran Mazumdar-Shaw on Thursday called for more investment in research and development to drive innovation and foster culture of intellectual property. She highlighted how the country, already the world's largest exporter of generics and a major player in vaccine production, can achieve greater value by nurturing innovation. Mazumdar-Shaw called for a shift in focus toward value creation through innovation. "India ranks 14th in terms of value in the global pharma landscape. We need to invest in R&D and foster a culture of intellectual property to capture greater value," she said. Addressing a session during the Global Bio-India 2024 event, she positioned the country as a future global leader in biosciences and innovation. Mazumdar-Shaw emphasized India's unique advantages in becoming a global bio-innovation hub, citing the nation's rich scientific talent, robust technological capabilities, and entrepreneurial drive. "Biology is not only the most exciting and ...

Lenacapavir drug hailed as 'the closest we have ever been to an HIV vaccine', is currently sold by US pharma major Gilead at Rs $42,250 for the first year

The widespread nature of the issue stretches across different regions of the country, including Himachal Pradesh, Hyderabad, Waghodia, Vadodara, Andhra Pradesh, and Indore

India's stand on intellectual property rights (IPRs) and pharma issues in proposed trade agreements balances innovation with public health needs, ensures availability of affordable medicines and promotes growth of generic medicine industry, a GTRI report said on Friday. Think tank Global Trade Research Initiative (GTRI) said that by opposing demands of developed nations on issues like 'data exclusivity' and 'patent linkage' in free trade agreements (FTAs), India ensures that generic drug manufacturers get greater market access and cost of life-saving medicines gets reduced significantly. "India's approach underscores a commitment to balancing innovation with public health needs, adopting a flexible interpretation of TRIPS to align with its developmental goals, and preventing the establishment of unfair monopolies, especially in the pharmaceutical sector," the GTRI paper said. It added that this stance reflects a broader effort to protect traditional knowledge and ensure the ...

Doctors Without Borders (MSF), Public Eye, and Delhi Network of Positive People expressed concern that the deal, which is nearing completion, includes harmful intellectual property (IP) proposals

Leaked IP chapter suggests potential hindrance to affordable medicine production

In the last nine years, around Rs 26,000 crores of poor people's money has been saved through the Jan Aushadhi Kendras

Jan Aushadhi and trade generics together constitute 20-22% of pharma market volumes

Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Esomeprazole Magnesium delayed-release capsules indicated for short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Esomeprazole Magnesium delayed-release capsules of strengths 20 mg and 40 mg, Granules India said in a regulatory filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP. Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison ...

Zisavel capsules will be available as 100 mg capsules and will be priced at Rs 7,992 for 7 capsules

Companies must start preparing their business models to adjust to the reality of the shift to medical practitioners prescribing only generic molecule names

The IMA has written to Union Health Minister Mansukh Mandaviya seeking withdrawal of National Medical Commission (NMC) regulations on mandatory prescription of generic drugs till there is quality assurance of all medicines. The doctors' body also expressed concern over the regulations which bar doctors from attending conferences sponsored by pharma companies saying such a prohibition warrants reconsideration. It demanded associations and organisations should be exempted from the purview of NMC regulations. Members of the Indian Medical Association and Indian Pharmaceutical Alliance on Monday had met Mandaviya and expressed their concerns over the NMC regulations. The National Medical Commission (NMC) in its 'Regulations relating to Professional Conduct of Registered Medical Practitioners' stated that all doctors must prescribe generic drugs, failing which they will be penalised and their licence to practice may also be suspended for a period. It also asked doctors to avoid prescrib

60% respondents wanted doctors to mention names of both branded drug and generic version

From now on, your doctors can only prescribe generic medicines to you, or they will be penalised or, worse, could lose their license. Watch the video to find out

India is the world's largest producer and exporter of generic drugs. But how did it manage to do so? Let us find out here