Following cases of child deaths linked to toxic cough syrups, the central government has launched a major nationwide campaign to strengthen monitoring and quality checks of pharmaceutical manufacturing units. Since December 2022, more than 1,040 drug manufacturing units across the country have been inspected under a risk-based inspection system. During these inspections, action has been initiated against more than 950 units where quality-related deficiencies were detected. The action includes issuing show-cause notices, stopping production, suspending or cancelling licences, and issuing warnings to companies.
To strengthen quality control in the pharmaceutical sector, the government conducted a comprehensive inspection drive in coordination with state authorities. Officials said special focus was placed on companies involved in manufacturing cough syrups. More than 1,100 cough syrup manufacturers underwent special audits across the country. In addition, samples of cough syrups available in the market were collected on a large scale and tested to identify substandard, adulterated, or unsafe medicines at an early stage.
According to central government data, the scope of drug quality testing has increased significantly over the past five years. During 2021-22, a total of 88,844 drug samples were tested. The number increased to 96,713 samples in 2022-23. In 2023-24, authorities tested 1,06,150 samples, while 1,16,323 samples were examined during 2024-25. In 2025-26, the number of tested samples further increased to 1,41,322. These inspections and laboratory tests were conducted to ensure that medicines available in the market meet required safety and quality standards.
Over the last five years, a total of 5,49,352 drug samples have been examined. Of these, more than 14,702 samples failed to meet prescribed quality standards, while 1,613 samples were found to be completely fake or adulterated. Regulatory authorities initiated action against the concerned manufacturers, companies, and supply chain operators involved in these cases. The government has maintained a strict approach against counterfeit and poor-quality medicines.
After the toxic cough syrup incidents, changes have also been introduced in drug safety regulations. The government has amended standards under the Indian Pharmacopoeia (IP) 2022 to improve medicine safety. Under the revised system, testing for harmful chemicals such as Diethylene Glycol (DEG) and Ethylene Glycol (EG) has been made mandatory before cough syrups are released into the market. These toxic substances were linked to several international cases involving child deaths caused by contaminated cough syrups. The new guidelines aim to ensure that medicines reaching consumers comply with strict safety requirements.
Experts believe that regular inspections, digital monitoring systems, and strict quality testing are essential to prevent the circulation of fake and substandard medicines. Strengthening supervision of raw materials, manufacturing processes, packaging systems, and distribution networks can help detect irregularities and improve accountability across the pharmaceutical supply chain.
The government has directed state drug control departments to maintain continuous monitoring of suspicious medicines and manufacturing units. Officials said the risk-based inspection system will be further strengthened in the coming period. Any company or manufacturer found violating quality standards will face strict legal action. The government aims to maintain public confidence in the pharmaceutical sector and ensure that citizens receive safe, effective, and quality-assured medicines.
