India’s pharmaceutical standards authority has started random inspections of drug factories to check for regulatory compliance, the health ministry announced on Tuesday, a fallout of an Indian company’s cough syrups being linked to deaths in Gambia.
The inspections by the Central Drugs Standard Control Organisation (CDSCO) are being conducted on the directions of health minister Mansukh Mandaviya in collaboration with state drugs regulators across the country, the ministry said in a statement.
The ministry has constituted a committee of two joint drugs controllers at CDSC headquarters in Delhi to monitor the inspections to ensure quality compliance mandated by the Drugs & Cosmetics Act, 1940.
“An action plan for nationwide inspection of manufacturing units which are identified to be at the risk of manufacturing Not of Standard Quality (NSQ), adulterated, or spurious drugs was made prior to carrying out of inspections,” the ministry said.
Cough syrups made by New Delhi-based Maiden Pharmaceuticals have been linked with the death of at least 66 children in the African nation of Gambia, denting India’s image as the pharmacy of the world. A recent inspection at Maiden’s factory in Haryana found gaps in good manufacturing practices, norms of which are laid down by the World Health Organisation (WHO).
The random inspection of drug factories to check for standards was suggested by experts assigned to investigate the Maiden case, according to people familiar with the development who declined to be named.
“The objective of drug regulation is to ensure safety, efficacy and quality of the drugs available in the country,” the health ministry said on Tuesday. “The drug control administration is required to ensure that manufacturing units comply with Drugs & Cosmetics Act, 1940 and Rules thereunder especially to the requirements of Good Manufacturing Practices.”
In a briefing on October 5, WHO had issued a medical product alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Maiden.
While test reports did not find any contamination in the samples of cough syrups lifted for inspection by Indian regulatory authorities, the government admitted that the company defaulted on WHO good manufacturing practices compliance, based on which it was asked to stop production by the state drugs regulator.
“During the investigations as per Drugs and Cosmetics Act and Rules thereunder, it was observed that the firm was manufacturing and testing drugs without adhering to and in contravention of the various GMP requirements of Schedule M and Schedule U of the Drugs Rules,” the regulator had said. “Firm has not maintained and not produced complete records of manufacturing and testing as per Rules. Various documents were examined by the investigating team, which clearly indicates that the firm is not meeting the requirement of Drugs Rules, 1945 under Drugs and Cosmetics Act, 1940 across its manufacturing and testing activities.”
“In view of the seriousness of the contraventions observed during the investigation and its potential risk to the quality, safety and efficacy of the drugs being produced, all he manufacturing activities of the firm is being stopped with immediate effect under section 22(1d) of Drugs and Cosmetics Act 1940, and Rules framed thereunder till further order, in public interest, without prejudice to further action in the matter.”
