February 29, 2024

MOON Desk: In a major crackdown on companies manufacturing spurious or substandard drugs, regulators either cancelled licenses of or halted manufacturing at 18 companies. Permission to manufacture particular products was also cancelled for three companies, according to sources in the Union Health Ministry.

Showcause notices were issued to 26 companies after inspections by joint teams of central and state drug control offices.

The action came after the first phase of inspections at 76 companies across 20 states and Union Territories. The government has identified 203 companies based on reports of samples collected at random; it was informed. More inspections will take place in the coming days, according to officials.

The action comes at a time when India is trying to peg itself as a global pharma major by providing quality medicines at affordable rates. At a global summit held in India recently, the government showcased its generic medicine store — Jan Aushadhi Kendras.

The development, however, also comes after products from Indian pharmaceutical companies were linked to deaths in other countries. Four syrups manufactured by Haryana-based Maiden Biotech were linked to the deaths of 70 children in the Gambia, and two syrups manufactured by Noida-based Marion Biotech were linked to deaths of 18 children in Uzbekistan.

Manufacturing was halted at both companies after an inspection was conducted by joint teams. While samples from Maiden Biotech were found to be of standard quality after the inspection, samples from Marion failed and further action was initiated against the company.

In another incident, an eyedrop from a Chennai-based firm was linked to 55 adverse events, including loss of vision and one death due to bloodstream infection in the United States. The company voluntarily recalled its product from the market, but an inspection was conducted and production of eyedrops was halted at the facility.

The action was initiated around 15 days ago to ensure that companies do not manufacture spurious or substandard drugs. It was also to ensure that they follow good manufacturing practices.

At a chintan shivir organised by the Union Health Ministry in February, drug regulators and other stakeholders had discussed the possibility of fixing a timeline for implementing Schedule M of drugs and cosmetics Act that details good manufacturing practices. Although the schedule already exists, not all companies follow it at present, and the more stringent WHO-GMP norms are followed by fewer companies still, an official said.

 

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