India’s drug regulatory authorities have initiated more than 250 "actions" after inspections of the premises of 275 drugmakers by central and state authorities, the Union health ministry told Parliament on Friday.

It is not clear from the answer how many companies among the 275 inspected received multiple notices or actions.

The health ministry said the Central Drugs Standard Control Organisation (CDSCO) and state drug controllers had conducted “risk-based inspections” of 275 premises, which led to more than 250 actions such as showcause notices, stop-production orders, suspensions and licence cancellations by the state licensing authorities.

“The firms (had) been identified on risk criteria like the number of drugs declared as not of standard quality, complaints, (and) criticality of products,” minister of state for health Bharati Pravin Pawar said in a written reply to a question from Ganesh Singh, an MP.

Singh had asked the health ministry for details of the steps taken by the government to strengthen regulatory monitoring mechanisms and ensure the quality and safety of medicines in the country.

Pharmaceutical executives said the results of these inspections cannot be extrapolated to the rest of the drug manufacturing industry because they appeared to have been concentrated on what one executive described as the “lowest rungs” of the industry.

India has 3,000 drug companies and 10,500 manufacturing units. The 275 sampled for inspections had been picked on the basis of certain risk criteria.

It comes to something like testing the worst performers in a classroom — a large proportion are likely to fail, another executive said. Both requested not to be named.

Prashanth Reddy, a Hyderabad-based lawyer who specialises in intellectual property and has co-authored a book on India’s drug regulatory system, said the CDSCO ought to have made public the detailed results of the inspections.

“The public — patients and doctors — need to know which companies lost their licences or were asked to stop production for what kind of transgressions and what happened to the drugs that were produced in these premises,” Reddy said.

Health ministry and CDSCO officials on Friday did not respond to a query from this newspaper asking whether details of the inspections’ findings and the actions taken against the 250 companies would be placed in the public domain.

Health ministry officials had in March 2023 announced that the ministry had cancelled production licences or issued stop-production orders to 18 companies and issued showcause notices to 26 other companies for failing to comply with regulatory requirements.

The officials did not name any company but released a list of 20 states and Union Territories where inspections had taken place.

These were Andhra Pradesh, Bengal, Bihar, Delhi, Goa, Gujarat, Haryana, Himachal Pradesh, Jammu and Kashmir, Karnataka, Madhya Pradesh, Maharashtra, Puducherry, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttar Pradesh and Uttarakhand.