India’s pharmaceutical regulatory body, the Drugs Controller General of India (DCGI), has mandated the recall of approximately 45 medicinal products that were found to be below the quality standards. This action is part of an ongoing effort by the Central Drugs Standard Control Organisation (CDSCO) to ensure public safety by monitoring and controlling the quality of pharmaceutical products in the country. Along with the recall, DCGI has also initiated legal proceedings against the manufacturers of five counterfeit drugs.

Speaking at the Confederation of Indian Industry (CII) Pharma and Life Sciences Summit in New Delhi on October 9, 2024, Rajeev Singh Raghuvanshi, the DCGI, addressed recent claims regarding the alleged ban on 50 fake medicines. Raghuvanshi clarified that these reports were misleading and incorrect, stating that, “They are not fake medicines. They were ‘not of standard quality’ medicines. There is a difference between the two. Only five of them were spurious in our terminology, which you can talk as fake.”

The CDSCO plays a critical role in maintaining the quality of drugs in India. Every month, it samples and tests around 2,000 drug products available on the market. Among these, 40 to 50 products often fail to meet the required parameters. However, these failures do not always indicate a significant health risk. Raghuvanshi explained that many of these deviations are minor and do not necessarily pose a threat to consumer health. Products that fall short of quality standards are listed on the CDSCO portal, allowing transparency in the regulatory process.

Raghuvanshi emphasized that only five of the products identified recently were classified as spurious or fake. “The one picture which is being given is that there were 50 fake medicines which we banned. That was completely wrong. They were not fake medicines and they were not banned. They were just notified as not of standard quality,” he explained. This distinction between "substandard" and "spurious" is crucial, as it affects how the CDSCO handles such cases.

When asked about the steps taken following the notification of these substandard and spurious drugs, Raghuvanshi said that the CDSCO follows a systematic procedure. Once a drug is identified as not meeting the required standards or as being spurious, the manufacturers are immediately notified and asked to recall their products from the market. This recall process is crucial in preventing further distribution and usage of these non-compliant drugs.

Regarding the spurious drugs, Raghuvanshi explained that investigations are underway to trace the supply chain and bring those responsible to justice. "We have identified the spurious products, and then action starts from the person who sells, from where we have samples, and then we do the mapping of the whole supply chain," he said. He acknowledged that the process of prosecuting those involved in the sale and distribution of these fake drugs is still ongoing.

India’s Drug and Cosmetics Act provides a comprehensive legal framework to address issues related to fake and substandard medicines. Raghuvanshi noted that the law includes provisions for both administrative and legal actions against offenders. Depending on the severity of non-compliance, the CDSCO may recommend prosecution or other administrative measures to address the issue. He added that the organization is committed to bringing the culprits to book and ensuring that such incidents are dealt with swiftly and effectively.

In September 2024, the CDSCO released a list of over 50 drugs, including commonly used medications like antacids and paracetamol, that were found to be either substandard or spurious. This list highlights the continued vigilance of the CDSCO in monitoring the quality of pharmaceutical products in the Indian market. While some of these drugs failed on minor quality parameters, others posed more serious concerns, leading to their recall or further investigation.

(Input from various sources)

(Rehash/Yash Kamble/MSM)