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Generic Drugs
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 ...
India has not accepted the demand of the UK for inclusion of a 'data exclusivity' provision in the free trade agreement, announced on May 6, in a bid to protect the interests of the domestic generic drugs industry, an official said. During the negotiations, the UK had asked to include this provision in the trade pact. "But India has not accepted that. There is no fear for the Indian generic industry from this agreement. In fact, it is our very important objective to see that the generic drug industry flourishes," the official said. The sector plays a key role in India's exports, which are also growing. Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products. In the pharmaceutical sector, drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new medicine. By gaining exclusive rights over this data, innovator companies can prevent their competitors
Gland Pharma on Wednesday said it has received approval from the US health regulator for a generic medication to treat conditions related to high pressure in the eye. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Latanoprostene Bunod Ophthalmic Solution, (0.024 per cent), the drug firm said in a statement. The company's product is bioequivalent and therapeutically equivalent to Bausch and Lomb, Inc's Vyzulta ophthalmic solution, it added. The product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity, Gland Pharma said. According to IQVIA, the product had sales of around USD 171 million in the US for the 12 months ending February 2025. Shares of Gland Pharma on Wednesday ended 1.04 per cent down at Rs 1,398.35 apiece on the BSE.
Generic drugs made in India are related to 54 per cent more severe adverse events, including hospitalisation, disability and death, compared to the equivalent generic drugs made in the US, a new study has found. The findings were largely driven by 'mature generic drugs' -- or those that had been in the market for a long time. "Where generic drugs are manufactured can make a significant difference," said co-author John Gray, a professor of operations at The Ohio State University's Fisher College of Business. A generic drug is a medicine created with the same chemical as an already marketed brand-name drug with same dosage, safety and effectiveness. The drug is allowed to be sold once patents for the original brand expire. The results, published in the journal Production and Operations Management, show that all generic drugs are not equal, even though patients are often told that they are, Gray said. "Drug manufacturing regulation and, therefore, quality assurance practices, differ
Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture its generic version of Paliperidone extended-release tablets, used to treat schizophrenia. The approval by the US Food and Drug Administration (USFDA) is for Paliperidone extended-release tablets of strengths 1.5 mg, 3 mg, 6 mg, and 9 mg, Zydus Lifesciences said in a regulatory filing. These tablets will be produced at the group's manufacturing site at SEZ, Ahmedabad, it added. Paliperidone extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia, acute treatment of schizoaffective disorder as monotherapy and acute treatment of schizoaffective disorder as an adjunct to mood stabilisers and/or antidepressants, the company said.
The drug formulations market in India is expected to grow at a CAGR of 9-10 per cent over the next decade with Jan Aushadhi outlets anticipated to emerge as a much stronger player in the country, according to Glenmark Pharmaceuticals. The domestic formulations market is estimated to be at Rs 2 lakh crore, with a growth rate of 11 per cent over the past two decades. "It is projected that the domestic formulations market will maintain a compound annual growth rate (CAGR) of 9-10 per cent over the next decade," the Mumbai-based drug maker said in its Annual Report for 2023-24. As the Trade Generics and Jan Aushadhi channels expand, it is anticipated that these channels could collectively contribute 30 per cent to the market volume in ten years, it stated. The Jan Aushadhi initiative aims to enhance access to cost-effective, unbranded generics by scaling up to 25,000 franchise pharmacies by 2026, it said. "It is estimated that Jan Aushadhi procurement could account for 3-5 per cent o
Glenmark Pharmaceuticals on Monday said its US-based subsidiary has introduced a generic medication used for eye itching. Glenmark Therapeutics Inc, USA has launched Olopatadine Hydrochloride Ophthalmic Solution (OTC) in the US market, the Mumbai-based drug maker said in a regulatory filing. Fabio Moreno, Head of OTC Sales & Marketing, Glenmark Pharmaceuticals Inc, said the launch of Olopatadine Ophthalmic Solution (USP, 0.1 per cent), addresses a growing demand for a new supplier in this category. "This addition highlights our commitment to meeting market needs and providing high-quality over-the-counter solutions for our customers," Moreno said.