In 2018, India revised Schedule M (Good Manufacturing Practices) of the Drugs and Cosmetics Rules to bring it on a par with the World Health Organization (WHO) standards. But it’s only now that these will be implemented, that too in a phased manner. Pharma companies exporting to other countries had to be WHO-GMP compliant, but the implementation of Schedule M for domestic companies hadn’t been enforced; indeed, just about a fifth of the 10,500 drug-manufacturing units in the country are WHO-GMP compliant, according to the Union health ministry.
The government has now set deadlines for mandatory implementation—companies with a turnover of Rs 250 crore will have to comply within the next six months and those with a turnover below Rs 250 crore have to do it within a year. This is undoubtedly a course correction, but the time taken for implementation—five years—is symptomatic of the ailments that drug regulation in the country suffers from.
India’s image as pharmacy to the world has been sullied by repeat instances of drug quality and safety failure—whether it is the allegations of toxins in Maiden Pharmaceuticals’ and Marion Biotech‘s cough syrups killing children in Gambia and Uzbekistan, respectively, or the bacterial contamination of eye-drops exported by Global Pharma Healthcare to the US. Between 2019 and 2023 (year-to-date), the US Food and Drugs Administration has raised 21 Official Action Indications for Indian drugs, which means failure to comply with its standards.
In some cases, these have resulted in import alerts, meaning the drug-makers concerned are banned from supplying to the US. The situation isn’t very different at home. In 2020, drugs made by a Himachal Pradesh-based manufacturer killed 12 children in neighbouring Jammu & Kashmir—after its products had been flagged at least 19 times by various government drug laboratories. This is quite telling of how drug regulation in the country continues to exist in silos.
Making the revised GMPs mandatory for all pharma companies fixes only part of the problem. Compliance will involve at least 11 specific changes to the manufacturing process, including the introduction of a pharmaceutical quality system, rigorous product quality review and stability tests, validation of equipment etc. These will certainly help assure the market on the quality and safety of drugs. A risk-based inspection of 162 manufacturing units and 14 testing labs found several failures—from absence of testing of ingredients before use to faulty design of testing areas.
While regulatory intent is the supplement drug, the main agent of treatment of the ailing drug regulation in India is fixing its fragmented structure. There are 37 nodal agencies across states and Union Territories under the Central Drugs Standard Control Organisation (CDSCO) umbrella, which means a double whammy of regulatory chaos and regulatory silos. On top of that, the federal nature of drug regulation means states that want to promote ‘ease of manufacturing’ at the cost of ensuring high-quality production are more likely to take an approach of regulatory forbearance.
Indeed, centralised regulation and licensing have been a long-standing demand, since the days of the Mashelkar Committee in 2003. Now that the regulatory intent is clear, India must walk the tightrope between nurturing industry and ensuring top-notch quality. The draft Drugs, Medical Devices, and Cosmetics Bill 2022 fell quite short of this on many counts. The government, in consultation with the states, must fix the enforcement gaps so that innocent lives do not fall victim to lax regulation.