Scroll.in The Jan Vishwas Bill, 2023, passed by Lok Sabha on July 27, is in the news for its lenient approach to the crime of manufacturing “not of standard quality” (NSQ) drugs. But comparatively less attention is being paid to the adverse impact that the legislation will have on an equally serious issue, which is the regulation of pharmacies that have a key role to play in India’s drug supply. To begin...
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Maiden pharma, under WHO scanner for Gambia kids' deaths, flouted norms in 4 states -Milan Sharma
-IndiaToday.in The Central Drugs Standard Control Organisation (CDSCO) has not yet barred the company from operations in India even as many of its medical products made for Indian use have also been found to be of substandard quality, often flagged by authorities. Ever since Maiden Pharmaceuticals has come under the scanner of the World Health Organisation (WHO) after being flagged for the four cough syrups manufactured in India and exported to Gambia...
More »A new legislation that mirrors the old -Dinesh S Thakur and Prashant Reddy T
-The Hindu The New Drugs, Medical Devices and Cosmetics Bill is antiquated and needs to be revised The Union Health Ministry recently published a new draft Bill to replace the antiquated Drugs and Cosmetics Act, 1940. While we salute the Ministry for recognising the need for a new legislation, there is much to disagree with the new Bill. To begin with, although the Ministry has described it as being consistent with the...
More »Generic medicines in a digital age -Dinesh S Thakur & Prashant Reddy T
-The Hindu We need a legal mechanism to ensure that all generics are of the same standard as the innovator product The Prime Minister’s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has led to a flutter. If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug,...
More »Generics vs big pharma, reloaded -Shamnad Basheer
-The Hindu The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what it considered to be a backdoor extension for data exclusivity norms in the country. It pointed to the recent government proposal to change the four-year time limit for State-level drug...
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