 "WHO's good manufacturing norms to be made compulsory for all drug firms")
After allegations that cough syrups produced in India were connected to deaths overseas, the Ministry of Health and Family Welfare (MoHFW) could shortly notify proposed amendments to rules in order to make good manufacturing practice (GMP) compulsory for all pharmaceutical firms, according to a report by Mint.
The Centre recently made GMP mandatory for micro, small and medium enterprises manufacturing drugs. Only 2,000 of the 10,500 manufacturing units in the country have the World Health Organisation's GMP certification. GMP stipulates essential standards to improve product quality through control measures related to materials, methods, machinery, and processes.
Recently, the Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, held a meeting with drug manufacturers and industry stakeholders. Meetings are also being held with state drug controllers to spread awareness about enforcing the new GMP regime.
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The lack of uniformity in existing regulations has led to inconsistent enforcement and underdeveloped testing infrastructure. In India, over 100,000 drug samples are tested annually, but a lack of coordination between states and the central government can cause delays in inquiries and subsequent actions.
One of the state drug controllers told Mint that pharma companies have several queries regarding implementing the new changes.
Mint reported that Raghuvanshi communicated to pharma stakeholders that GMP under schedule M is under revision, and it is under the active consideration of the health ministry to publish final notification on the revised schedule. One-day regional workshops will be held across India to provide information about the revised schedule M requirement.
The first such meetings were conducted in Hyderabad, New Delhi, and Baddi last week. Similar meetings will be conducted in Mumbai, Kolkata and Ahmedabad in the coming days.
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The proposed amendment in Schedule M states that large firms (with a turnover exceeding Rs 250 crore) have six months and MSMEs (with a turnover below Rs 250 crore) have 12 months to implement the GMP standards.