Drug Controller General of India (DCGI) Dr. Rajiv Singh Raghuvanshi has recently clarified to the pharmaceutical industry that there is no room for further leniency on the issue of implementation of Revised Schedule M for the MSME pharmaceutical units in the country. Inaugurating the conference session of the Pharmac South Expo in Chennai recently, the DCGI unequivocally clarified to the pharmaceutical industry that the government remains resolute in the implementation of the Revised Schedule M, and the industry should not anticipate any further extension for compliance. To bring the Indian pharmaceutical quality standards on par with the international quality standards, the Union Health Ministry had notified the Revised Schedule M on December 28, 2023 for which the Ministry had released the draft guidance way back in 2018. The notification mandates that the drug manufacturers with annual turnover of more than Rs. 250 crore have to comply with the Revised Schedule M within six months from the date of publication of the rules and for MSMEs with less than Rs. 250 crore annual turnover, the timeline has been fixed as 12 months from the date of publication of notification. For the companies which are above Rs. 250 crore, the Revised Schedule M has already come into effect and the regulatory authorities have started inspections. Since then the MSME pharma units in the country have been knocking at the doors of the government demanding at least two more years to implement the Revised Schedule M. But, the Union Health Ministry in February last year rejected it and issued the final notification extending the deadline for implementation of the Revised Schedule M by just one more year, till December 2025, for the MSMEs. Industry associations representing the MSME pharma units still have been demanding to the government to extend the deadline and they have been hopeful of one more extension. But the DCGI has now said it all.
No doubt, a quality boost was the need of the hour for the Indian pharmaceutical industry, especially in the backdrop of the fact that for the last some years, the Indian pharmaceutical industry’s image has taken a severe beating following the WHO holding Indian pharma companies accountable for exporting contaminated medicines in the aftermath of deaths of several children in Gambia and Uzbekistan. Even though the country has come a long way to adorn the epithet of 'the pharmacy of the world', the ‘Gambian tragedy’, and other subsequent similar incidents in some other countries, was a rude reminder to the Indian drug authorities to maintain the quality of pharmaceutical products produced in the country. More importantly, the recent Coldrif cough syrup tragedy which claimed 26 innocent children in Madhya Pradesh due to contamination of drugs proved to be the proverbial last nail in the government’s decision not to extend the deadline any further. Obviously, the industry is hoist with its own petard as it should have been more careful on quality issues, especially after the Gambian tragedy. So, the Ministry has its own compelling reasons to insist on implementing the Revised Schedule M at the earliest. Dr. Raghuvanshi has rightly said that the Revised Schedule M standards are not bureaucratic hurdles, but essential safeguards against preventable health tragedies like the one happened in Gambia and Uzbekistan, and more recently in Madhya Pradesh. By mandating rigorous analysis of raw materials and systematic quality testing, the revised GMP standards provide a blueprint to eliminate the lapses that led to recent health crises. No doubt, stringent adherence to updated GMP is the only path forward to safeguard India's reputation as the pharmacy of the world. The industry should not wait for further extension. It should pull up its socks to implement the Revised Schedule M in letter and spirit. |