By Sunil Garodia
First publised on 2022-12-31 07:54:11
The position of India as the pharmacy of the world (for supplying generic medicines at low cost) is in danger after two successive incidents of supply of allegedly sub-standard and/or spurious products. Close on the heels of ruckus raised by the death of more than 66 children in Gambia (which was allegedly flagged by WHO without proper preliminary inquiry) by drinking paediatric cough syrups made in India by Haryana-based Maiden Pharmaceuticals which allegedly deed not meet the prescribed standards (an inquiry by the Indian government exonerated the manufacturer of any wrongdoing) comes the allegation from Uzbekistan that many children have died there after consuming cough syrups made and supplied by Noida-based Marion Biotech Private Limited. Drug regulators in India have asked the firm to stop production pending an investigation.
Even though nothing has been heard further about the Gambia case (although one is sure that the Central government is taking it up in all forums), this new case complicates matter further. In addition, data from Central Drugs Standard Control Organization (CDSCO) shows that out of 1487 samples picked up by regulatory agencies from drug manufacturers' facilities across India, 83 or 6% were found to be sub-standard. Greed, and the desire to make extra profits, leads some dirty fish among drug manufacturers to use sub-standard material or play around with accepted formulas to endanger lives. This cannot be allowed. Manufacturers have to adhere to good manufacturing practises (GMP) and ensure that no sub-standard product leaves their manufacturing facilities.
The Indian Pharmaceuticals Alliance and the Central and state governments have a huge role in ensuring this. There should be mandatory random checks of export consignments (in addition to periodic checks at manufacturing facilities). Drug manufacturers and the government have to all to ensure that India pharmaceuticals products meet accepted world standards and there is no deviation to maintain India's place as the prominent drug supplier in the world. Drug manufacturers found indulging in cutting corners should be punished as per law and their licences should be cancelled even if one wilful deviation is detected and the promoters should be blacklisted and denied licence to manufacture pharmaceutical drugs in future.