With the applying submission deadline ending on 11 Might, there was a flurry of functions, on condition that failure to satisfy the standards would end in measures, together with show-cause notices, production-halt orders, suspension and even licence cancellation.
In 2023, the federal government notified the revised Schedule M of the Medicine and Cosmetics Act, 1945, to implement GMPs at par with the World Well being Group’s (WHO) requirements for drug-making firms.
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Within the first part, drugmakers with an annual turnover of ₹250 crore and above have been to compulsorily observe the GMPs inside six months, whereas the smaller corporations got a 12 months.
MSME producers should absolutely implement the GMPs by 31 December. Nevertheless, they have been purported to submit a proposal to the Central Licensing Authority by 11 Might explaining their upgradation plan.
Queries despatched to the well being ministry spokesperson weren’t answered until press time.
Notably, India is tightening scrutiny within the wake of domestically manufactured medicines failing high quality checks abroad as a consequence of alleged contamination. For example, cough syrups manufactured by Indian corporations have been allegedly linked to the deaths of kids in creating international locations, together with Gambia and Uzbekistan, in 2022 and 2023.
The GMP compliance will make sure that medication manufactured on the home vegetation have security, high quality and efficacy.
World participant
This assumes significance because the Indian pharmaceutical business is a big international participant and the biggest provider of generic medication, accounting for about 20% of the worldwide provide. It manufactures about 60,000 generic manufacturers throughout 60 therapeutic classes. India’s pharmaceutical exports stood at $30.47 billion in FY24-25, as per Pharmexcil, a physique arrange by the federal government to advertise the export of pharma merchandise.
The Central Medicine Customary Management Organisation (CDSCO) has developed a web-based system, the On-line Nationwide Medicine Licensing System (ONDLS), a portal for drug makers to submit functions.
“The federal government is mandatorily asking all of the pharmaceutical firms to enhance their high quality. CDSCO has obtained roughly. 1,000 functions from the corporations submitting their upgradation plans. The federal government is inspecting the functions now,” mentioned the first official.
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A number of days earlier than the 11 Might deadline, Union well being secretary Punya Salila Srivastava additionally raised a priority in a assessment assembly, highlighting that only a few corporations have submitted their functions to the DCGI.
“Nevertheless, as per the info obtainable, only a few corporations have submitted their functions requesting extension of timelines of implementation of revised schedule M,” mentioned the well being secretary in a letter to the state and Union territory governments.
The well being secretary directed all of the state drug regulators and pharmaceutical producers to take up the problem on precedence to adjust to GMP inside the stipulated time and submit the applying for extension on the ONDLS portal.
“We’ve issued an advisory to firms inside our jurisdictions following the instructions of the well being secretary, ” mentioned a drug controller requesting anonymity.
Deadline extension
“All the main associations have requested an extension for submitting the applying. The deadline of 11 Might is over, and those that have given their software will likely be given an extension to implement GMP by 31 December 2025, and those that didn’t apply means they’ve complied with the foundations and laws. Strict actions will likely be taken towards those that usually are not following the compliance,” mentioned the second official.
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Final 12 months, the Union authorities launched the Revamped Prescription drugs Expertise Upgradation Help Scheme (RPTUAS) to assist drug makers improve their manufacturing items. Underneath this scheme, the federal government offers monetary help to corporations to improve their vegetation to adapt to international requirements.
Harish Jain, Federation of Pharmaceutical Entrepreneurs, mentioned, “There are two circumstances: first, a number of the businesses are following GMP compliance, and second, some might not be capable to elevate the funds and should shut down. A number of reminders have been issued by the governments associated to GMP. We additionally sensitised our member firms to observe GMP.”
Key takeaways
- The Medicine Controller Normal of India obtained 1,000 functions from MSME drugs producers detailing their plans to adjust to Good Manufacturing Practices earlier than the 31 December deadline.
- Firms failing to satisfy GMP requirements may face manufacturing halts, licence suspensions, or cancellations.
- India revised the Act governing drug manufacturing to implement WHO-standard GMP practices.
- The Central Medicine Customary Management Organisation developed the On-line Nationwide Medicine Licensing System to streamline GMP functions.
- The well being secretary raised considerations that many corporations did not submit their functions, whereas pharmaceutical associations requested deadline extensions.
