The national control laboratory for assuring the availability of high quality drugs is a conduit for the distribution of substandard products, the Comptroller and Auditor General (CAG) has said.
The National Institute of Biologicals (NIB) was set up 16 years ago to ensure that patients get authenticated medicines and vaccines with long expiry periods. But, “instead of becoming an instrument for preventing distribution of substandard products in the country, [the NIB issues certificates] without proper testing”, the CAG said in a recent report.
Despite having resources and a vast infrastructure — the government has spent Rs256 crore on the institute — the NIB continues to release many batches of biological products without independent quality assurance testing, the report said.
The NIB could not achieve its intended objectives of systematic examination of the quality of biologicals, and developing national reference standards and human resource development in the field, the report said.
The CAG said that when it came to drug imports, the country was compelled to rely on claims of safety by foreign manufacturers or regulatory authorities.
Also, the NIB lacks “good laboratory practices, compliant processes and procedures” and has been found to have “committed serious scientific lapses and malpractice”.
