Thiruvananthapuram: The sale of fake and substandard medicines in India is becoming increasingly widespread, with thousands of drug samples failing safety standards and being removed from circulation, according to official data.

In the last fiscal year alone, authorities withdrew 3,104 medicines nationwide due to non-compliance with quality norms, while 245 counterfeit medicines were seized. During FY 2023–24, 2,988 drug samples were declared substandard.

Inspection authorities said that despite conducting surprise raids across multiple states, including in the Ayurveda sector, completely curbing counterfeit drug operations remains a challenge.

Following the seizure of fake inhaler medicines worth over ₹2 lakh in November, enforcement teams intensified inspections across Kerala, leading to several cases being registered in Thiruvananthapuram, Kollam, Kottayam, Alappuzha, Kannur, Kozhikode and Thrissur districts.

However, the Drugs Control Department has not made public the details of these seizures, prompting concerns over transparency in the crackdown on counterfeit medicines.

Legal loopholes helping counterfeit drug operations

The amendments introduced last year to the Drugs and Cosmetics Act have unintentionally created a safeguard for those involved in fake drug manufacturing and illegal pharmaceutical trade.

Under the revised provision, accused parties may approach the Central Drugs and Standards Control Organisation (CDSCO) and settle offences by paying fines instead of facing court proceedings. It is alleged that these exemptions particularly benefit rapidly growing pharmaceutical units in certain North Indian cities.

The Union Health Ministry states that since 2022, more than 960 inspections have been carried out with state drug control departments, resulting in action including notices and licence cancellations against 860 offenders. However, enforcement appears insufficient to curb the scale of fake medicine production.

Weak surveillance system, limited government response

"India’s system to detect and prevent the sale of fake and substandard medicines remains weak. There is concern that the government has not adequately scrutinised how some companies can sell drugs 40 per cent below cost margins, despite a retail margin of only 14 per cent,” said A N Mohan, President of the All Kerala Chemists and Druggists Association.