India regulator asks states to implement uniform drug licensing norms to end quality gaps

NEW DELHI: India’s top drug regulatory body has reiterated the need for states to adopt uniform licensing guidelines for all drug manufacturing practices to maintain the same quality standards across the country.

Drug Controller General of India (DCGI) Dr. The aim of issuing a comprehensive guidance document mandating a dossier-based licensing system is to eliminate regional regulatory differences and implement a single, stringent standard for drug approvals in every state and Union Territory to ensure uniform product licensing across the country, Rajeev Singh Raghuvanshi said in a directive in February.

“The guidance is currently active and state licensing authorities have been requested to adopt the guidance document for uniform product licensing across the country and update DCGI on the actions taken in this regard,” an official said. By implementing good manufacturing practices, DCGI has effectively raised the bar for all domestic companies in India’s $50 billion pharmaceutical industry, the official added.

So far, registration of pharmaceutical products in India has generally been marked by a lack of uniformity. While the law provides a general framework, the lack of a standardized checklist meant that state licensing authorities could have varying requirements, leading to inconsistent assessments of drug quality and safety.

This fragmented approach has raised concerns about maintaining a singular standard of quality in India, which is considered the “pharmacy of the world” for its ability to produce cheaper generic drugs. With unified guidance, DCGI seeks to close gaps in the legislation and ensure that every manufacturer complies with the same criteria.

The move to a dossier-based approach means that the regulator will use “a more structured and comprehensive assessment of the relevant information contained in a dossier submitted by the applicant” rather than making decisions based on individual assessments.

Under the new protocol, manufacturers must submit comprehensive data through the online National Drug Registration System portal. DCGI emphasized that this was necessary to address concerns regarding the quality, safety and effectiveness of medicines.

Rigorous checklist

The regulator aims to “bring reliability and predictability to the regulatory system” by requiring standardized documentation.

The guidance document has developed a rigorous 41-item checklist divided into two critical sections. Part A focuses on administrative and facility details, such as the building’s layout and layout.

Part B deals with technical information related to the drug, such as stability data, process validation data and analytical method validation/verification data to prove its quality. It is noteworthy that the technical presentation is on Form 29, which acts as a valid “test licence”.

This form is important because it allows manufacturers to legally produce small batches for analysis, testing and inspection. It acts as a regulatory bridge between research and commercialization by ensuring that stability study data and certificate of analysis for the three consecutive batches required in the checklist are generated under controlled, legal conditions.

However, former drug controller of Haryana, Dr. GL Singhal said many small companies lack the expensive machines needed to conduct these tests.

“While major companies may be compliant, the rest of the industry may struggle to overcome ‘paper compliance’ to truly make better drugs. The government should ensure that compliance is followed by the industry,” Singhal said.

Questions sent to the health ministry spokesperson and the DCGI office remained unanswered till the time of publication.