Drugs regulator to turn the screws on spurious medical products

A key focus will be on strengthening the surveillance and control of medical product advertisements aimed at healthcare professionals. The WHO recommended enhanced training and stricter oversight to ensure that all promotional, marketing, and advertising materials provide accurate and non-misleading information about medical products.

Further, the CDSCO plans to mandate that all central and state authority websites feature a dedicated reporting page for sub-standard and falsified (spurious) products.

Tighter rules for drug ads and easier reporting for public

“As part of the plan, a core component of the CDSCO’s revamped approach will be the strengthening of surveillance and control over medical product advertisements, particularly those targeting healthcare professionals. Keeping a closer eye on medical product advertisements will help patients in getting accurate information, safer treatment choices, reduce the dangers of self medication, and better doctor-patient conversations. As per Indian regulations, companies cannot make advertisements of drugs following in schedule H, H1 and X. These drugs are controlled and sold in the prescription of registered medical practitioners,” an official said.

“The proposal for implementation of WHO’s recommendations were discussed in the Drugs Consultative Committee meeting last month chaired by the Drugs Controller General of India (DCGI). It was agreed upon to take suitable action for each of the recommendations,” the official said.

Tracking suprious and substandard drugs

Notably, one of the important WHO’s recommendations is to combat the menace of spurious and sub-standard drugs: preventing, detecting, and responding to “not of standard quality” and “spurious medical drugs,” alongside a robust market surveillance program and stringent control over promotional, marketing and advertising activities.

The WHO has recommended that all Central and State government websites provide a dedicated ‘substandard and falsified (SF) reporting page – with information for the public on how to specifically report SF products. Reports from this mechanism should be subject to the SF report handling procedure for that organization.

“This is an important step towards increased transparency and public participation in identifying or reporting the SF products. This will empower the public to directly report suspicious products and these reports will then be properly investigated,” said the official, adding that a communication from DCGI may shortly be released to all the States/UTs to implement the action points in a uniform manner.

“The government is also doing risk-based assessment of pharma firms to keep a track on the drug manufacturing and actions have also been taken,” the official said.

The Indian pharmaceutical market is set to reach$100 billion by 2025, as per government projections.India is the largest provider of generic drugs globally and is also known for its affordable vaccines.

“These measures will not only help protect patients but also safeguard the integrity of compliant pharmaceutical companies,” said Nikkhil K. Masurkar, chief executive officer, Entod Pharmaceuticals.

Masurkar said that when a spurious or falsified version of a company’s drug appears in the market, it triggers significant challenges, even when the original manufacturer has followed all regulatory protocols. “Patient safety becomes the immediate concern, but the ripple effects are far-reaching. The company can face public scepticism, reputational damage, and erosion of trust among healthcare providers, all because a counterfeit product misrepresents their brand. What makes it more difficult is that the manufacturer is often unfairly perceived as responsible, even when the fault lies entirely with external bad actors. The company is then forced to redirect time, resources, and focus towards legal action, crisis communication, and internal audits, diverting energy from innovation and patient engagement. Despite being the victim, the brand often suffers disproportionately, with long-term reputational impact that’s hard to undo.”

Queries sent to the health ministry spokesperson and WHO remained unanswered.