FOPE writes to govt raising concerns about new Schedule M amendment

The Federation of Pharma Entrepreneurs (FOPE) has written a letter to the Ministry of Health & Family Welfare voicing strong concerns over the new Schedule M amendment, and urging the government to reconsider its impact on the sector. The new Schedule M states that manufacturing premises must be exclusively used for the production of drugs, barring any other manufacturing activities. The letter highlights that this amendment, applicable to both existing and new facilities, poses significant challenges for the pharma and nutra industry.

The letter points out that internationally, regulatory bodies such as the USFDA, EU, MHRA, MCC, and TGA allow facilities to manufacture both pharma products and dietary supplements, as long as they comply with pharma standards. Many Indian facilities, approved by both local and international regulatory bodies, currently produce and supply both pharma products and dietary supplements, contributing significantly to employment, foreign exchange earnings, and consumer satisfaction.

The letter also cautions that the proposed amendment could have far-reaching implications for the industry.

With regards to exports, it accentuates, that companies may face a dilemma in choosing between manufacturing drugs or dietary supplements, leading to potential business standstill. Losses, disruptions in exports, and damage to India’s supply chain credibility may result, hampering the “Make In India” philosophy. Thus, the amendment could jeopardise India’s opportunity to become a key global supply source.

Outlining the impact on the Indian market, the letter informs that existing facilities, with approvals for both drugs and dietary supplements, may face significant disruption, affecting supply to the Indian market. Establishing new facilities could take up to four years, during which consumers may be deprived of their regularly consumed products.

The industry association, through its letter, says that existing facilities, which adhere to high drug manufacturing standards, are equipped with high-quality infrastructure and protocols to prevent cross-contamination, should be allowed to continue with production of both drug and dietary supplements.

The industry also urges the government to revoke the amendment through the letter.