The IPA has also proposed that the CDSCO publish drug alerts only after a full investigation has been conducted and samples are conclusively classified as NSQ Indian pharmaceutical companies, under the Indian Pharmaceutical Alliance (IPA), have called for reforms to the country’s drug quality inspection system, aiming to align it with global standards. This comes after a recent alert by the Central Drugs Standard Control Organisation (CDSCO) identified over 50 drugs as “Not of Standard Quality” (NSQ), raising concerns about the safety of medicines in India.
In a letter to Dr Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), the IPA outlined several proposals to streamline the drug investigation process. Business Today has reviewed the letter. The industry body urged the CDSCO to give companies 30 days’ notice to respond to allegations about drug samples before releasing such information to the public.
“This development has caused confusion between the terms ‘counterfeit’ and ‘spurious’, making it harder for consumers to verify the quality of their medications,” says Sudarshan Jain, Secretary-General of the IPA. “Clearer distinctions are needed to prevent misinformation that affects both consumers and the pharmaceutical industry’s reputation.”
The IPA’s letter suggests that drug inspectors should specify the source of the sample — whether from a licensed or unlicensed premises — when sending it for testing. Furthermore, the IPA recommends that companies be given time to classify the samples as either NSQ or spurious, with justifications provided.
The IPA has also proposed that the CDSCO publish drug alerts only after a full investigation has been conducted and samples are conclusively classified as NSQ. According to the IPA, samples found to be spurious should not be made public, as these do not involve the original manufacturer.
“These improvements would bring India’s drug investigation process in line with global practices seen in regulated markets such as the European Union and the United States, where drug alerts are issued only after thorough investigation,” Jain explains.
In response, Raghuvanshi said that the government has recalled 45 drugs identified by the CDSCO as being substandard or counterfeit. He clarified misconceptions about the CDSCO report, noting that while 45 drugs were flagged for quality concerns, they are not all fake and, therefore, have not been banned. Instead, only five have been specifically classified as spurious, which involves a higher degree of falsification akin to counterfeiting. He added that stringent actions are being taken against the manufacturers of these five spurious drugs.
Raghuvanshi further emphasised the distinction between substandard and spurious drugs. Substandard drugs generally have issues such as insufficient active ingredients or improper formulation, whereas spurious ones usually involve false or non-existent labelling. Counterfeit drugs are fake medicines that are deliberately and fraudulently misrepresented in terms of identity, source, or composition.
“Upon receiving information about drugs that are either substandard or spurious, the CDSCO immediately notifies the manufacturers and orders a recall of the affected products,” Raghuvanshi said. The IPA’s push for reform comes at a time when counterfeit and substandard drugs remain a significant problem in India’s pharmaceutical market.
To tackle this, Jain says, “We are focusing on three key areas. The first is capability building. Our aim is to educate our field teams to quickly report counterfeit issues to the relevant authorities and the company itself. We are also supporting the government in capacity building to handle these challenges.”
Jain also calls for emphasis on process improvements. “We are stressing the importance of purchasing only from authorised retailers and ensuring that retailers buy from authorised stockists. For example, in Maharashtra, control departments are being set up to ensure purchases made outside the state are reported to the US FDA."
Jain further highlights the importance of legislative changes and enforcement, particularly in improving the reporting of counterfeit incidents and strengthening the role of testing laboratories. “We have filed a case in the Supreme Court, advocating for police involvement in the reporting and handling of serious counterfeit cases,” he adds.
Healthcare professionals and pharmaceutical stakeholders stress consumers also play a crucial role in ensuring the medicines they purchase are genuine.
Alok Malik, President and Head of India Formulations at Glenmark Pharmaceuticals Limited, advises, “It’s important to buy medicines only from trusted retailers and avoid unregulated online platforms to reduce the risk of counterfeit drugs.” He also emphasises the importance of obtaining a bill when purchasing medications. “A bill serves as proof of purchase and can provide a record in case of recalls or adverse effects."
Malik further notes that genuine medicines should display visible batch numbers and expiry dates, which confirm regulatory compliance. He encourages consumers to check for high-quality packaging, legible fonts, correct spellings, and intact seals. “Be cautious of heavily discounted medicines, as counterfeit drugs are often sold at lower prices,” he warns. If consumers suspect their medicines are counterfeit or of poor quality, they are encouraged to report the issue. Regulatory bodies like the CDSCO have portals for complaints, which help authorities address these concerns.
According to data from the Union Health Ministry, in 2022-23, the government identified 3,053 drugs as substandard and 424 as spurious or adulterated. To combat the prevalence of spurious and substandard drugs, the government has amended the Drugs and Cosmetics Act to impose stricter penalties on the production of such drugs. Some offences are now categorised as cognisable and non-bailable, and special courts have been set up across states and Union Territories to handle cases related to drug quality offences.
Additionally, amendments to the Drugs Rules in December 2023 revised Good Manufacturing Practices, reinforcing the need for stringent standards in pharmaceutical production. The CDSCO also works with state drug control organisations to ensure the uniform administration of the Act.
The introduction of barcodes and QR codes on the packaging of top medicine brands by the Drugs Controller General of India (DCGI) in August 2023 has further boosted efforts to tackle counterfeit drugs. These codes allow consumers to verify details such as the manufacturer, batch number, and expiry date, helping to combat counterfeit drugs and improve patient safety.
Pharmaceutical companies are also working to ensure genuine and high-quality medicines reach patients. Glenmark, for instance, has introduced unique product identifiers and QR codes on packaging to aid consumers in verifying authenticity. Malik adds, "Scanning the QR code with your smartphone provides instant verification of authenticity."
Several companies, including Sun Pharma and Alkem Laboratories, have clarified that they did not manufacture the drugs labelled as NSQ or spurious following the drug regulator’s alert, which tarnished their reputation and may have financial implications for them because of misinformation.