New Delhi: The government will shortly notify a revised version of good manufacturing practices (GMP), at par with the World Health Organization (WHO) standards, for small pharmaceutical companies with an annual turnover of less than 250 crore.
Companies with an annual revenue of up to Rs 250 crore fall under the micro, small, and medium enterprises (MSMEs) category.
As part of the government’s guidelines, which were announced in July 2023 and notified in December, drugmakers with an annual turnover of more than Rs 250 crore were to compulsorily follow GMP within six months, while those with a turnover of less than Rs 250 crore were supposed to do so over a 12-month period.
“Already GMP is applicable for bigger companies that have annual turnover of Rs 250 crore or above. The government notified the GMP guidelines last year on 28 December. However, smaller firms were given time for one year to create an enabling environment to comply with GMP rules. A revised version of the GMP at par with WHO standards is in the works and will shortly be notified to be effective from December onwards,” a government official aware of the matter said.
The government is also doing risk-based assessment of these bigger companies to check whether GMP is being followed, and suitable action is being taken against errant companies, the official said on the condition of anonymity.
Queries sent to a health ministry spokesperson remained unanswered till press time.
Earlier this month, Union health minister J.P. Nadda said in parliament that more than 300 measures, including show-cause notices, production-halt order, suspension, cancellation of licences /product licences etc., were ordered based on the risk-based assessment of the drug firms by the state licensing authorities and Central Drugs Standard Control Organisation (CDSCO) under the provisions of the Drugs Rules 1945.
Last year, the Centre revised Schedule M of the Drugs and Cosmetics Rules, 1945, which prescribes good manufacturing practices, or GMP standards for drug firms.
GMP is a set of mandatory guidelines for pharmaceutical companies to maintain the quality of products by way of controlling the quality of raw materials, methods, machines, processes, personnel, facility and environment, among other things, used in the manufacture of pharmaceutical items.
This revision of Schedule M was done in view of allegations of contaminated cough syrups manufactured by Indian firms that were allegedly linked to deaths of children in developing countries, including 66 in Gambia and 68 in Uzbekistan in 2022.
The GMP compliance would secure India’s image as the pharmacy of the world and bring the country’s drug manufacturing capability at par with global standards, especially those issued by the WHO. Moreover, this would ensure the production of globally-acceptable quality of drugs.
Mint recently reported about the Drugs Controller General of India (DCGI) considering issuing and renewing licences only to those pharmaceutical firms that can prove they follow GMP.
