India Moves to Centralise Licensing of All Sterile Drugs After Quality Lapses

India is preparing to bring all sterile drug products under a single central licensing system, a move aimed at tightening oversight of injectables and other sterile medicines following persistent quality failures.

The proposal would transfer products currently licensed by state authorities to the Central License Approving Authority (CLAA), according to officials familiar with the matter. Implementing the change would require amendments to the Drugs Rules, 1945, and is intended to replace a fragmented approval landscape with uniform requirements for licensing and inspection nationwide.

The push follows the detection of about 240 injection samples that were not of standard quality in 2025-26, a figure that excludes other sterile dosage forms. A government document cited recent quality problems both in India and abroad, including contamination reported in metoprolol injection and an adenosine injection solution.

At present, the central licensing framework covers only selected sterile products — large-volume parenterals, sera and vaccines, along with certain cell, stem-cell, gene and recombinant DNA-derived products. Other sterile medicines remain under state licensing authorities. The concern is that this split produces uneven assessment of applications and inconsistent inspection of manufacturing facilities across states, with reviews for additional products after an initial licence proving particularly inconsistent.

The proposal would expand the CLAA scheme to all sterile drug products irrespective of category, with applications and related regulatory processes handled through the government's online ONDLS portal.

The timing reflects growing scrutiny of medicine quality as India serves both domestic and export markets. The country's generic injectable market was valued at about $3 billion in 2024 and is projected to reach $7.6 billion by 2033, making robust oversight increasingly important as production expands.

Public health experts backed the shift. Dr Rajeev Jayadevan, former president of the Indian Medical Association's Kochi chapter, said a centralised licensing and regulatory system would help ensure uniform manufacturing standards without being vulnerable to variations between states. He noted that sterile products by their nature demand stringent adherence to Good Manufacturing Practices, and that any quality lapse carries serious consequences for patient safety. Unlike a tablet or syrup, an injection bypasses several of the body's natural protective barriers, he added, so contamination can introduce harmful material directly into the bloodstream and cause severe or fatal complications.

Industry voices largely welcomed the move. Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance, which represents 23 leading drugmakers, described quality as the fundamental licence to operate in the pharmaceutical industry and said steps at both central and state levels advance the quality agenda for patient care.

Nikhil K Masurkar, CEO of Entod Pharmaceuticals, which makes ophthalmology solutions, supported tighter central oversight for sterile injectables given their direct administration into the body. He argued, however, that a risk-based framework distinguishing sterile injectables from other sterile dosage forms would strengthen patient safety without creating unnecessary regulatory duplication or delays for established, compliant manufacturers, noting that eye drops already meet stringent sterility standards and carry a fundamentally different risk profile.

Queries sent to the health and family welfare ministry, the office of the Drugs Controller General of India, and to Sun Pharmaceutical Industries, Cipla, Mankind Pharma and Zydus Lifesciences remained unanswered.