Gambia deaths: Drug regulators launch nationwide inspection

Weeks after a tragedy in The Gambia where children died reportedly after consuming made-in-India cough syrups, India’s drug regulating agencies have launched a nationwide inspection of production units manufacturing sub-standing medicines, the Union Health Ministry said here on Tuesday, without disclosing the number of such units that are under the scanner.

The country-wide inspection is being carried out jointly by the Central Drugs Standard Control Organisation (CDSCO) – the apex regulator - with the State Drug Control Organisations to ensure production of safe, efficacious and good quality medicines.

"An action plan for nationwide inspection of manufacturing units, which are identified to be at the risk of manufacturing Not of Standard Quality / adulterated / spurious drugs was made prior to carrying out the inspections,” the ministry said. Repeated queries on further details on such units didn’t elicit any response.

A broad idea about the ills in the pharmaceutical manufacturing process can be gauged from the inspection of Maiden Pharmaceuticals manufacturing unit in October in the wake of paediatric deaths in The Gambia.

Read | Gambia deaths: Govt blames WHO for premature deduction

The checks at the Haryana-based plant had revealed multiple contraventions in the production process and absence of paperwork meant to establish the quality of raw materials, finished goods and the integrity of the manufacturing process.

The firm, for instance, didn’t perform process validation and analytical method validation for the four cold and cough syrups that were exported and failed to produce in-process testing reports. Moreover, the batch numbers, the manufacturer’s identity and manufacturing and expiry dates of chemical excipients were not found in the purchase invoice.

Monthly alerts issued by the CDSCO typically show that the concerns about poor quality medicine are not limited to one or two companies, but widespread. The regulator issued NSQ alerts on 51 samples in October, 59 in September, 45 in August, 53 in July, 26 in June and 41 in May, 2022.

A Health Ministry official said joint inspections were being conducted following a standard operating procedure to rectify such shortcomings in the manufacturing process, which in turn would help improve the quality of medicines made in India.

A committee consisting of two Joint Drug Controllers has been constituted at the CDSCO headquarters to monitor the process of inspection, reporting and subsequent action for compliance with the Drugs and Cosmetics Act, 1940 and the rules framed under the law.

"It is a welcome move, but the government has to spell out how it selects the units. Also will there be punitive actions from the government or a set of recommendations on how to improve the production facilities? More clarifications from the ministry are needed,” S Srinivasan from the All India Drug Action Network told DH.

Activist Dinesh Thakur described the move as an eyewash. “The issue is not who is conducting inspections. The competence of the inspectors from either organisations is not that different. The question is what process they follow and whether they make their findings public. Let’s see,” said Thakur, who recently co-authored a book on India’s drug regulatory system.