New Delhi: India plans to bring all sterile drug products under a central licensing system, tightening oversight of injectables and other medicines, after about 240 injection samples were found to be not of standard quality in fiscal 2026, according to two officials familiar with the matter.
The proposal would shift products that are currently licensed by state authorities to the Central License Approving Authority, or CLAA, system, the official said, who didn't want to be named, citing rules. It would require amendments to the Drugs Rules, 1945, and is aimed at replacing a fragmented licensing system with uniform requirements for approval and inspection across the country.
About 240 injection samples were found to be not of standard quality in 2025-26, excluding other sterile dosage forms, according to a government document reviewed by Mint. It cited recent quality problems in India and abroad, including contamination reported in metoprolol injection and an adenosine injection solution.
“A centralized licensing and regulatory system for the entire country is a welcome step that will help ensure uniform manufacturing standards across the nation, without being vulnerable to individual state licensing variations,” said Dr Rajeev Jayadevan, a public health expert and former president of the Indian Medical Association’s Kochi chapter.
“These sterile products, by their very nature, require stringent adherence to Good Manufacturing Practices (GMP). Any lapse in quality can have serious consequences for patient safety,” the document said.
The government’s concern is that the split can result in differences in how applications are assessed and manufacturing facilities are inspected across states. The document said the review of applications for additional products after an initial license is particularly inconsistent.
“It is proposed that all sterile drug products, irrespective of category, be brought under the CLAA scheme,” the document said. The change would expand the scope of the central licensing system and allow applications and related regulatory processes to be handled through the government’s online ONDLS portal.
The proposal comes as India seeks to strengthen confidence in the quality of medicines made for both domestic and overseas markets. India’s generic injectable market was valued at about $3 billion in 2024 and is estimated to reach $7.6 billion by 2033, according to India Brand Equity Foundation (IBEF), making quality oversight increasingly important as production expands.
Queries emailed to the health and family welfare ministry, the office of the Drugs Controller General of India, Sun Pharmaceutical Industries Ltd., Cipla Ltd., Mankind Pharma Ltd. and Zydus Lifesciences Ltd. remained unanswered till press time.
Industry experts backed the move, saying stronger oversight would help raise quality standards.
“Quality is the fundamental license to operate in the pharma industry. All steps, both at the central and the state level, are in the direction to advance the quality agenda for patient care,” said Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance, which represents 23 leading pharmaceutical companies.
Medical experts said the need for tighter oversight is particularly important for sterile medicines. “Unlike a tablet or syrup taken by mouth, a medicine bygiven as an injection bypasses several of the body’s natural and powerful protective barriers,” said Dr Jayadevan.
A contaminated injection can introduce harmful material directly into the bloodstream, potentially causing severe or fatal complications, he said.
“I strongly support tighter central regulatory oversight for sterile injectable products, particularly given that these medicines are administered directly into the body and any failure in sterility or quality can have serious and potentially systemic consequences for patients," said Nikhil K Masurkar, CEO of Entod pharmaceuticals, which manufactures ophthalmology solutions.
“Eye drops are already required to comply with stringent sterility and manufacturing standards and their risk profile and route of administration are fundamentally different from injectable medicines. A risk-based regulatory framework that differentiates between sterile injectables and other sterile dosage forms would, in my view, strengthen patient safety without creating unnecessary regulatory duplication or delays for established, compliant manufacturers,” he said.