India’s Ministry of Health and Family Welfare has given small and medium-sized drugmakers three months to submit details of how they intend to comply with new good manufacturing practice (GMP) requirements.
 
The Central Drugs Standard Control Organization (CDSCO) published the revised GMPs in late 2023 and gave companies with turnovers of less than 2.5 billion rupees ($29 million) one year to comply. Last month, The Economic Times reported that half of the 10,000 drug manufacturing units in India may have missed the deadline and the government agreed to give companies more time
 
Starting from 11 February, companies have three months to submit their upgrade plans. Manufacturers that provide the information by the deadline will have until the end of 2025 to comply with the new GMP requirements.
 
CDSCO has created a form for companies to submit. Manufacturers need to include details of a gap analysis that addresses their plants, equipment, and other GMP elements, plus their plan for resolving the areas of non-compliance. Indian officials believe raising standards will make the country more competitive.
 
“The revised Schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products being manufactured in India,” the government said. “The new regulations would enable the pharma companies to not only strengthen their domestic position but also become more competitive globally.” [India Ministry of Health and Family Welfare]