NEW DELHI: Of the 1.16 lakh drug samples tested, over 3,000 were declared not of standard quality in 2024-25, the Rajya Sabha was informed on Tuesday.
Union Health and Family Welfare Minister J.P. Nadda informed the House that 245 drug samples were declared spurious or adulterated during the same period, while 961 prosecutions were launched for the manufacturing, sale, and distribution of spurious or adulterated drugs.
In the past three years, over 3 lakh drugs were tested, and 8,000 drug samples were declared not of standard quality (NSQ).
The minister also said that isolated cases regarding spurious, adulterated, or sub-standard drugs are received from time to time.
As part of quality monitoring and in order to assess the regulatory compliance of drug manufacturing premises in the country, the Central Drugs Standard Control Organization (CDSCO), in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022.
Firms have been identified based on risk criteria such as the number of drugs declared not of standard quality, complaints, and the criticality of the products.
As of now, 905 units have been inspected, resulting in 694 actions being taken.
These actions include Stop Production Orders (SPOs), Stop Testing Orders (STOs), license suspensions/cancellations, warning letters, and show-cause notices, depending on the severity of non-compliance.
This initiative has provided valuable insights into manufacturing practices and has led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework, the Health Minister said.
In cases where drug samples are declared NSQ by the Drugs Testing Laboratories under CDSCO, the respective manufacturing firms are asked to immediately recall and stop further distribution of the non-standard quality drugs in the market.
Further, based on the outcome of investigations, actions are taken by the concerned licensing authorities under the provisions of the Drugs and Cosmetics Act and the rules made thereunder, such as stop production orders, stop testing orders, license suspensions/cancellations, warning letters, and show-cause notices.
The government is implementing the Strengthening of the Pharmaceutical Industry (SPI) Scheme in the country.
This scheme aims to strengthen existing infrastructure facilities by providing financial assistance to pharmaceutical clusters for the creation of common facilities; to facilitate and upgrade production facilities of existing small and medium pharmaceutical companies with an average turnover of less than Rs. 500 crore to meet the standards specified in the revised Schedule M to the Drugs Rules, 1945, and the World Health Organization - Good Manufacturing Practices (WHO-GMP); and to promote knowledge and awareness in and about the pharmaceutical industry by undertaking studies, building databases, and sponsoring events for knowledge and experience sharing within the pharmaceutical sector.
Moreover, to strengthen the drug regulatory system in the country, the Union Health Ministry is implementing a centrally sponsored scheme, Strengthening of States’ Drug Regulatory System (SSDRS), with an approved outlay of Rs. 850 crore.
The scheme envisages upgrading existing state laboratories, setting up new drug testing laboratories, and upgrading existing state drug control offices across the country.
Under the scheme, funds totaling Rs. 756 crore have been released to States and Union Territories as part of the central share. Seventeen new drug testing labs have been constructed, and 24 existing labs have been upgraded in various States and Union Territories.
