Federation of Pharma Entrepreneurs (Fope), a pharma lobby group that works with MSMEs, said any clampdown will affect not only exports but also the domestic market.
In a recent diktat, the government said action will be taken against pharma units that are flouting the norms by manufacturing nutraceuticals, health supplements and drugs in the same facility.
Executives of Fope recently met the health secretary and the Drug Controller General of India (DCGI), seeking an exception to select units as was given earlier.
One of the executives said the government officials said they will discuss it internally and “reconsider it”.
Harish K Jain, president of Fope, said, “We have given a written representation regarding our concerns.”An exception was earlier provided to the units established prior to December 2001, he said. “Subsequently, this concession was extended to all manufacturing establishments by the Drugs Controller General India under his letter dated March 1, 2007, based on the decision of the Drugs Consultative Committee in its 37th meeting.”As per a recent notice by the DCGI, an enforcement and surveillance drive carried out by the Food Safety and Standards Authority of India (FSSAI) found that many units in Himachal Pradesh have dual licences under FSS Act 2006 and Drugs and Cosmetics Act 1940 for manufacturing nutraceuticals, health supplements and drugs in same factory.
Fope’s Jain said enforcement of the rule will impact both exports and domestic supply as it will take a long time for the industry to align with this rule. During their meeting with the DCGI and the health secretary, Fope representatives asked the regulator to revoke the rule.
