The Centre has received numerous representations from state governments and Union territories, underscoring the urgent need for a more robust drug regulatory system, the officials said. Seized of the issue, the union health and family welfare ministry is finalizing a comprehensive plan to upgrade existing infrastructure and expand the technical workforce.
Persistent quality issues risk significant economic losses and increased international regulatory barriers in the backdrop of a series of failures denting India’s image as the “pharmacy of the world.” During FY25, of a total of 116,323 drug samples were tested by central and state regulators. Of these, 3,104 were declared ‘not of standard quality’ (NSQ), while 245 samples were found to be spurious and adulterated.
Currently, seven Central Drug Testing Laboratories operate in Kolkata, Chennai, Mumbai, Chandigarh, Hyderabad, Guwahati, and Kasauli. There are also 35 state government laboratories to ensure quality control in drugs and cosmetics across India. The country has a total of 2,283 drug inspectors, including 400 personnel working for India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO).
There are currently 249 drug inspector posts vacant in the country, the government had said in parliament on 16 December.
The Centre currently runs a Strengthening of States’ Drug Regulatory System (SSDRS) with a ₹850-crore allocation for upgrading laboratories, setting up new testing facilities and modernizing drug control offices. The scheme operates on a cost-sharing basis; wherein the Centre and states bear the cost in a 60:40 ratio.
The government’s new plan, likely to be announced in the budget for FY27 on 1 February, involves extending the scheme’s extension for the next five years till FY31 as Version 2.0.
“A critical gap in the system is manpower sustainability and for new labs to be effective, states must commit to permanent staffing, rather than relying on temporary contracts, ensuring that technical expertise remains within the regulatory system,” said one of the three government officials cited above, requesting anonymity.
In one of the most damning incidents, Indian-manufactured cough syrups have over the last few years been linked to over 140 deaths globally, including in countries such as Gambia, Uzbekistan and Cameroon, due to ethylene glycol poisoning. In India too, recent tragedies linked to ‘Coldrif’ syrup led to at least 24 deaths in late 2025. Eye drops manufactured in the country have also been linked to adverse reactions in the US.
Routine sampling at home continues to flag a significant number of sub-standard batches. The latest case in point being state drug regulators launching a massive crackdown on a common paediatric cough syrup ‘Almont-Kid’ manufactured by Tridus Remedies due to life-threatening contaminants, including ethylene glycol that was nearly 15 times the permissible safety limit.
“These incidents have underscored the urgent need for more frequent inspections and a robust laboratory network to detect contaminants such as diethylene glycol before products reach the market, ensuring that Indian exports meet the stringent safety benchmarks of global regulators,” said the second government official cited above.
“While the final budgetary allocations are still being determined, the initiative aims to enhance capabilities and ensure more rigorous monitoring of pharmaceutical quality nationwide,” said the third government official.
Keeping in mind revenue and economic growth forecasts as well as savings in revenue spending, the government takes a final call on budget allocations closer to its presentation.
Queries emailed to the spokespersons of the ministries of health and finance on 7 January remained unanswered until press time.
Health experts say strengthening drug testing competence and regulatory capacity is essential to protect public health as well as the global reputation of India’s pharmaceuticals.
Dr K. Srinath Reddy, former president of the Public Health Foundation of India (PHFI), a public health institution said, “Since suboptimal testing capacity and defective licensing processes in any state can permit countrywide dissemination and even the export of poor quality and potentially harmful drugs, we should not permit weak links to exist in our regulatory framework.”
“While the government funds new public sector labs, it should also mobilize and enhance underutilized testing capacity in medical colleges, universities, and research laboratories to build a larger network,” Dr Reddy added.
These upgrades are vital for patient safety, said Dr Aashish Chaudhry, managing director of Aakash Healthcare in Delhi. “A robust laboratory network is critical for maintaining accountability across the pharmaceutical value chain. Increased testing and enforcement will create benchmarks—from manufacturing to marketing—preventing the use of adulterated ingredients,” he said.
He pitched for the use of technology in inspections to make the regulatory system “more transparent and harder to manipulate compared to purely manual oversight”.
Dr Chaudhry said marketing firms, on their part, must also take onus. “Marketing firms should be held legally responsible for the products they sell, even if manufactured by third parties,” he said.
