Over 14,300 Drug Samples Fail Quality Tests in Five Years: Minister
New Delhi: Over the last five years, drug regulators tested more than 4.9 lakh samples of medicines, including cough syrups, ORS, protein powders, and nutritional supplements, across India, with over 14,300 samples flagged as Not of Standard Quality (NSQ) and nearly 1,600 found spurious or adulterated, the Parliament was recently informed.
The data was placed before during a recent Lok Sabha session when MP Dr Mohammad Jawed sought details of samples of cough syrups, medicines, Oral Rehydration Salts (ORS), protein powders, and other nutritional supplements tested by the Central Drugs Standard Control Organisation (CDSCO) during the last five years, State/UT-wise.
He also asked how many samples were found sub-standard or adulterated, what action was taken against erring manufacturers or distributors, whether any special drives had been launched to curb counterfeit health and nutrition products, and what steps were being taken to strengthen drug testing infrastructure across the country.
Responding to the queries, Union Health Minister Jagat Prakash Nadda informed the House that the manufacture, sale and distribution of drugs in India are regulated under the Drugs and Cosmetics Act, 1940, and its rules, through a licensing and inspection framework implemented by Central and State drug regulators.
Based on inputs received from State and Union Territory Drugs Controllers, the Government placed on record that 84,874 samples were tested in 2020–21, 88,844 in 2021–22, 96,713 in 2022–23, 1,06,150 in 2023–24, and 1,16,323 samples in 2024–25.Of these, 2,652 samples in 2020–21, 2,545 in 2021–22, 3,053 in 2022–23, 2,988 in 2023–24, and 3,104 samples in 2024–25 were declared Not of Standard Quality, while 263, 379, 424, 282 and 245 samples, respectively, were found spurious or adulterated.
The Minister added that the Food Safety and Standards Authority of India (FSSAI), along with State and UT food safety departments, also carries out regular surveillance, inspections, and random sampling of food and nutritional products under the Food Safety and Standards Act, 2006.
As per information received from various States/Union Territories Drugs Controllers (SDCs), the number of drug samples reported as not of Standard Quality/spurious/adulterated by the States/UTs Drugs Controllers during the last five years is as follows:
| Financial Year | No. of Drug Samples Tested | No. of Samples Declared Not of Standard Quality | No. of Samples Declared Spurious / Adulterated |
|---|---|---|---|
| 2020–21 | 84,874 | 2,652 | 263 |
| 2021–22 | 88,844 | 2,545 | 379 |
| 2022–23 | 96,713 | 3,053 | 424 |
| 2023–24 | 1,06,150 | 2,988 | 282 |
| 2024–25 | 1,16,323 | 3,104 | 245 |
On steps to prevent counterfeit and sub-standard medicines, the Minister stated that as a 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 like the number of drugs declared as not of standard quality, complaints, criticality of the products, etc.," the Minister stated.
"As of now, CDSCO along with SDCs have conducted risk-based inspections of more than 960 premises since December 2022, and based on findings, more than 860 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses, warning letters have been taken by the States/UTs as per the provisions of the Drugs Rules 1945," he added.
The Minister further informed that lists of drugs declared Not of Standard Quality, spurious or adulterated by Central Drugs Testing Laboratories are regularly uploaded on the CDSCO website under “Drug Alerts”, and enforcement action is initiated under the Drugs and Cosmetics Act, 1940.
To strengthen drug testing infrastructure, the Minister mentioned that the Government is implementing the centrally sponsored Strengthening of States’ Drug Regulatory System (SSDRS) scheme.
The scheme envisages upgrading existing State laboratories, setting up new drug testing laboratories, and upgrading existing State drug control offices in the country. Under the SSDRS Scheme, funds totalling Rs. 756 Crore have been released to States/UTs as part of the Central Share and 17 New Drug Testing Labs have been constructed, and 24 existing labs have been upgraded in various States/UTs.
