Pharma firms are pouncing on opportunity as patents on world’s second-bestselling drug, which goes by brand names Ozempic and Wegovy, are expiring in nearly 100 nations.
Industry insiders say any rise in duties on Indian generics will squeeze profits for Indian companies, but will also make the drugs costlier for patients in US.
The proposed extension for drugmakers in adopting Schedule M of Drugs and Cosmetics Act and Rules comes mainly at the behest of RSS-backed Laghu Udyog Bharti, it is learnt.
Under revised good manufacturing practices (GMP) norms, pharma companies will be required to assume onus for quality of drugs to ensure they do not place patients at risk.
Nearly 80 percent of small and medium drug manufacturing units in India do not follow good manufacturing practices (GMP) requirements, according to government estimates.
Delhi High Court accepted pharma companies’ argument that most banned drugs had been in use for over 30 years and said health ministry had not specified reasons behind ban issued in June.
Health minister concedes implementation of Schedule M of Drugs and Cosmetics Act has been poor. Timeline for adherence to norms for good manufacturing practices began on 1 August.
The health ministry has stepped up scrutiny of drugmakers in recent months after some cough syrups made in the country were linked to the deaths of at least 95 children overseas.
Modi met senior officials from top drug-makers like Zydus Cadila, Torrent & Wockhardt, and said their non-compliance is forcing govt to create a strict law.
The collusion between the new class of bureaucrats, politicians, businessmen and trade union bosses perpetuates itself partly because of the short-run benefits and partly because they see no way out of the system, wrote author MH Mody in 1980.
IAF is firming up plans to revamp airlift capabilities with medium transport aircraft that will be assembled in India & serve as its main workhorse. Embraer is leading contender as of now.
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