|
Union govt must fortify regulatory frameworks to strengthen trust in Indian medicines: Dr Jagashetty
|
|
Nandita Vijayasimha, Bengaluru
December 19 , 2025
|
|
|
The Union government must fortify regulatory frameworks to boost public confidence in the safety, efficacy, and quality of Indian medicines. As the demand for pharmaceuticals continues to grow, both domestically and globally, ensuring stringent oversight becomes crucial. It is here from prescription to patient, there is a need to build trust, said Dr BR Jagashetty, former Karnataka State Drugs Controller & former National Adviser (Drugs Control) to MoHFW & CDSCO and present special resource officer to FDA, Karnataka.
Strengthening regulatory mechanisms will not only safeguard public health but bolsters India’s reputation as a global leader in pharmaceuticals. By addressing gaps in enforcement, improving transparency, and fostering innovation in regulation, the government can build greater trust among consumers and international markets alike, he added.
India is titled as the ‘Pharmacy of the World,’ supplying affordable medicines globally. However, as we are known for volume, we must equally prioritize the value aspect specifically by uncompromising on quality of medicines to the domestic market, said Dr Jagashetty.
As a former regulator, Dr Jagashetty noted that regulation is not just about policing; but it is about education. In a rapidly evolving market, the safety of the patient cannot depend solely on the drugs controller. It requires a collaborative ecosystem involving clinicians, consumer groups, and informed patients.
Indian consumers need to understand about the current regulatory landscape. For instance, ‘Not of Standard Quality’ (NSQ) does not always mean a medicine is ‘fake’ or ‘poisonous’, but it means it has failed to meet the strict scientific parameters required for it to be effective, he said.
With recent legislative changes, like the Jan Vishwas Act, the government intends to improve the ‘Ease of Doing Business’ by decriminalizing minor technical offenses. While this supports industry growth, it inadvertently places a higher burden of vigilance on the rest of the ecosystem. We must ensure that ease of business does not translate to laxity in quality, he said.
Traditionally, a doctor’s role ends at writing the prescription. In today’s context, this must change. Clinicians are the most scientifically literate consumers in the chain. They are the bridge between the manufacturer and the patient. Doctors need to proactively report to the Pharmacovigilance Programme of India (PvPI) and there is a need for Rational Prescription where they play a crucial role in guiding patients away from irrational fixed-dose combinations and towards standard, single-ingredient formulations from reputable manufacturers, said Dr Jagashetty.
Now it is here consumer groups must step in as mediators. An individual patient often lacks the voice or the technical knowledge to challenge a substandard product. Consumer groups can bridge the gap by conducting independent random sampling of medicines from the market and publishing the results. This transparency encourages manufacturers to stay alert. It is also equally important to combat misinformation. Going by the surge in advertisements for Magical Remedies promising to cure incurable diseases like diabetes or vitiligo or cancer. This violates the Drugs and Magic Remedies (Objectionable Advertisements) Act. Therefore, consumer groups are essential in identifying these misleading claims and bringing them to the notice of the State drugs control department, said Dr Jagashetty.
Regulation is a continuous process of improvement. The government is tightening standards. By building a partnership where Doctors Act as gatekeepers, Consumer Groups Act as watchdogs, and Patients Act as informed participants, we can ensure that the medicines are safe and effective, said Dr Jagashetty.
|
|
|
|
|
|
|
|
TOPICS
|
The Food and Drug Administration (FDA), Maharashtra, has issued a public advisory urging citizens to report any misleadi ...
|
|
|
|
|