The Modi government at the Center has taken a very tough and decisive stand against those who play with the quality in the Indian pharmaceutical industry, which has strengthened its reputation as the 'Pharmacy of the World' in the country and the world. The Union Ministry of Health and Family Welfare, while issuing a new draft of amendment in the Drugs Rules, 1945, has proposed a stringent provision that if the medicine of any company does not meet the critical quality standards in the examination by the Government Analyst, then the manufacturing license of that company will be suspended with immediate effect without any administrative delay. The main objective of this step of the government is to root out all those loopholes due to which earlier even after the drug was declared 'Not of Standard Quality' (NSQ), it took weeks and months to take action on the concerned batch or unit due to lengthy legal and administrative processes. Under the new strict rules, the policy of 'Zero Tolerance' is now being implemented keeping the safety of patients paramount. Hurt on the old lax system: Now time will not be given in the name of show cause notice. In the previous system, when the sample of a medicine failed in the lab, the regulatory authorities used to issue 'Show Cause Notice' to the companies. After this, answers were sought from the companies, their clarifications were given and then a long round of hearing continued. During this entire paperwork process, companies were often left with the opportunity to continue production or resort to legal maneuvers, putting them at risk of unsafe medicines reaching patients. According to the new draft proposed by the Health Ministry, as soon as a drug is found to be substandard or contrary to the standards by a government analyst of the Central Drugs Standard Control Organization (CDSCO) or a State Drug Regulatory Authority, the licensing authority will have the direct power to immediately suspend the production license of that drug. This will reduce the time-gap between action and report to zero. The conditions for reinstatement of suspension will be very strict: Work will start only after verification. In the new rules, not only the process of suspending the license but also the process of revocation of suspension has been made very transparent and strict. According to the draft rules, the suspension of any drug manufacturing company will not be reinstated unless it fulfills the following mandatory conditions: Corrective and Preventive Measures (CAPA): The company will have to prove what was the reason for the technical deficiency in the drug and what concrete steps have been taken to ensure that it does not happen again in future. On-site verification by regulatory authorities: Mere submission of paper reports will not suffice; Physical verification of the manufacturing plant will be done by a team of drug inspectors and licensing authority. Passing re-testing: Factories will be allowed to reopen only after all samples from the modified batch are re-certified by independent government labs. India's preparedness on Schedule M and international standards This tough decision of the Union Health Ministry is an important step towards upgrading India's Schedule M in line with the 'Good Manufacturing Practices' (GMP) of the World Health Organization (WHO). After controversies related to some cough syrups and contaminated medicines in the past years, the Central Government has launched a massive campaign to make the drug manufacturing ecosystem of the entire country transparent. Under this, digital tracking, QR code based packaging, automated testing equipment and compliance with GMP have been made mandatory for all small and big pharma companies. The final draft of this new rule has been prepared following the recommendations of the 65th Drugs Consultative Committee (DCC) and the 92nd Drugs Technical Advisory Board (DTAB). Suggestions sought from the public and stakeholders within 30 days: While making this new draft rule public, the Union Health Ministry has given time to all the stakeholders, representatives of the pharma industry and the general public to submit their suggestions and objections within 30 days. Any citizen or industry representative can send his suggestions to the Deputy Secretary (Drugs) of the Health Ministry by post or through email. As soon as this 30-day consultation period ends, the government will finally notify this amended rule in the Gazette and implement it compulsorily in the entire country. What will be its wider impact on common patients and the Indian pharmaceutical industry? This strict decision of the Central Government will directly benefit 140 crore citizens of the country: Elimination of fake and substandard medicines: The circulation of medicines containing less effective or harmful chemicals in the market will be completely controlled. Credibility of Indian Pharma on the global stage: The credibility and quality of 'Made in India' medicines will get new assurance at the international level. Crackdown on careless manufacturers: Companies that use low-cost raw materials or ignore basic safety standards will have to close their plants or follow stricter standards. This stance of the government has clearly indicated that any level of compromise with public health and quality of medicines will not be tolerated.
