DCGI Refutes Claims of Labeling Drugs as Spurious, Calls Reports Misinterpretation

Speaking on the matter, Dr Raghuvanshi clarified that the reports were based on a misinterpretation of routine drug testing data, and only five of the drugs were found to be spurious.

The Drugs Controller General of India (DCGI), Dr. Rajeev Raghuvanshi, has refuted recent reports suggesting that the government labeled 50 commonly used drugs, including paracetamol and antibiotics, as spurious.  Speaking on the matter, Dr Raghuvanshi clarified that the reports were based on a misinterpretation of routine drug testing data, and only five of the drugs were found to be spurious.

Misinterpretation of Reports

The controversy arose after media reports surfaced claiming that the Central Drugs Standard Control Organization (CDSCO) had flagged 50 drugs as spurious, causing alarm among the public. However, Dr. Raghuvanshi clarified the situation, explaining that while some drugs were not up to standard, they were not classified as spurious or fake.

"In the recent news which came about three weeks back, there was a wrong interpretation of the notifications stating 50 drugs as not standard quality (NSQ), but they were not fake," Dr. Raghuvanshi stated. He further explained that only five out of the 50 drugs mentioned in the reports were deemed spurious, while the remaining were flagged as NSQ, which is a routine finding during drug quality assessments. “Only five of them were spurious, which you can term as fake, and the narrative that there were 50 fake medicines banned is completely wrong,” he emphasized.

Routine Drug Testing

The DCGI highlighted that detecting NSQ drugs is a standard part of CDSCO’s efforts to maintain quality and safety in India. Numerous medicines undergo testing each month, and a small percentage usually fail to meet one or more parameters.

"These were not fake medicines, nor were they harmful, but were identified as not meeting certain quality standards—a part of our routine process. Every month, we test and sample many medicines, and out of those, some 40-50 typically fail in one or more parameters," Dr. Raghuvanshi added. This routine testing ensures that medicines available to the public adhere to safety and quality guidelines, and any drugs failing these tests are dealt with appropriately to safeguard public health.

Regulatory Oversight on Spurious Drugs

Dr. Raghuvanshi reassured the public that the CDSCO follows strict procedures when addressing cases of spurious or fake medicines. Such cases are uncommon, but when detected, they are handled with established protocols designed to protect consumers.

"These spurious cases are handled promptly, and our systems are robust enough to manage these concerns effectively," he said. He also acknowledged the rising concern of misinformation spreading through social media regarding unsafe drugs. Still, he noted insufficient data to take immediate action against such claims. In response to a query on social media influencers promoting unverified drugs, he remarked that the issue is being monitored but requires more concrete evidence for regulatory action. “We acknowledge the potential for misleading information reaching the public, but it’s challenging to act swiftly without solid data.”

Industry Response and Legal Action

Following the initial reports, leading pharmaceutical companies conducted their own tests, with some disputing CDSCO's findings. Several drug manufacturers stated that their internal lab results showed some of the flagged samples spurious. This led the Indian Pharmaceutical Alliance (IPA) to file a Public Interest Litigation (PIL) in the Supreme Court, seeking enhanced powers for law enforcement agencies to tackle the growing problem of spurious drugs in the country. The IPA has urged for a coordinated approach between regulatory bodies and the police to curb the menace of counterfeit drugs, which pose a serious threat to public health.