Parliament: 379 Drugs Found To Be Spurious In Samples Tested In 2021-22, Says Govt

In a written response to a question, she stated that 84,874 samples were tested between April 2021 and March 2022, with 2,652 declared to be of poor quality and 263 found to be spurious.

The Drugs and Cosmetics Act, 1940, and its Rules, 1945, govern the manufacture, sale, and distribution of drugs in India. (Representational Image)

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Minister of State for Health Bharati Pravin Pawar on Tuesday (July 25) revealed the results of drug sampling conducted between April 2021 and March 2022 in a recent written to the Rajya Sabha, revealing concerning findings on drug quality. Over 2,500 of the 88,844 drug samples tested during this time period were determined to be "not of standard quality," raising questions about their efficacy and safety. Furthermore, 379 drugs were identified as forgeries, highlighting the problem of counterfeit medicines on the market.

The Minister also informed the Rajya Sabha that 592 prosecutions had been initiated against entities involved in the manufacture, sale, and distribution of counterfeit or adulterated drugs, demonstrating the government's commitment to enforcing stringent measures against those endangering public health.

Pawar responded to a written question by elaborating on steps taken by the government over the last five years to improve standardisation and quality in the pharmaceutical sector. The Drugs and Cosmetics Act of 1940 was amended in 2008 by the Drugs and Cosmetics (Amendment) Act to impose harsher penalties for the manufacture of counterfeit and adulterated drugs, with certain offences made cognisable and non-bailable.

States and union territories established special courts to expedite trials of offences under the Drugs and Cosmetics Act. Over the last decade, the Central Drugs Standard Control Organisation (CDSCO) has seen a significant increase in the number of sanctioned posts.

The government also amended the Drugs and Cosmetics Rules, 1945, to require applicants for manufacturing licences for oral dosage forms of some drugs to submit the results of a bioequivalence study with their applications. Furthermore, before granting a manufacturing licence, the amended rules require that the manufacturing establishment be jointly inspected by drugs inspectors from the Centre and the state.

Applicants must now submit evidence of excipient stability and safety to the State Licencing Authority before being granted a manufacturing licence. The CDSCO is responsible for coordinating the activities of State Drug Control Organisations, as well as providing expert advice through Drugs Consultative Committee (DCC) meetings to ensure uniformity in the administration of the Drugs and Cosmetics Act.

The Drugs and Cosmetics Act, 1940, and its Rules, 1945, govern the manufacture, sale, and distribution of drugs in India. To exercise regulatory control over drug-related activities, the country employs a licencing and inspection system administered by State Licencing Authorities (SLAs) appointed by respective state governments.

Manufacturers are required to follow the terms of the licence granted under the Act and Rules in order to manufacture drugs for sale and distribution in the country. Cases involving drug quality or safety are handled by state licencing authorities, who have the legal authority to take action, including prosecution, for any violations of licencing conditions.