NEW DELHI: India’s top drug regulator has reiterated the need for states to adopt uniform licensing guidelines for all drug-manufacturing applications to maintain the same quality standards across the country.
The aim of issuing a comprehensive guidance document mandating a dossier-based licensing system is to eliminate regional regulatory discrepancies and enforce a single, rigorous standard for drug approvals in every state and Union Territory to ensure uniform product licensing across the country, Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi said in a directive in February.
“The guidance is now active and state licensing authorities have been requested to adopt the guidance document for uniform product licensing across the country and update the DCGI on actions taken in the matter,” an official said. By enforcing good manufacturing practices, the DCGI is effectively raising the bar for all domestic companies in India’s $50 billion pharmaceutical industry, the official added.
Until now, the licensing of drug products in India was often marked by a lack of uniformity. While the law provided a general framework, the absence of a standardized checklist meant that state licensing authorities could have varying requirements, leading to inconsistent evaluations of drug quality and safety.
This fragmented approach raised concerns about maintaining a singular quality standard in India, considered the “pharmacy of the world” for its ability to manufacture cheaper generic drugs. With the unified guidance, the DCGI is trying to close regulatory gaps and ensure that every manufacturer adheres to the same criteria.
A shift to the dossier-based approach means that instead of making decisions based on individual evaluations, the regulator will use a “more structured and comprehensive evaluation of relevant information contained in a dossier submitted by the applicant.”
Under the new protocol, manufacturers must submit exhaustive data through the Online National Drugs Licensing System portal. The DCGI emphasized that this is essential to address concerns regarding the quality, safety and efficacy of the drugs.
Rigorous checklist
By requiring standardized documentation, the regulator intends to “bring credibility and predictability in the regulatory system.”
The guidance document has developed a rigorous 41-item checklist split into two critical sections. Part A focuses on administrative and facility-related details such as the site plan and layout of the building.
Part B pertains to technical information about the drug such as stability data, process validation data and analytical method validation/verification data to prove its quality. Notably, technical submission is in Form 29, which serves as a valid “test license.”
This form is important because it allows manufacturers to legally produce small batches for analysis, testing and examination. It acts as a regulatory bridge between research and commercialization, ensuring that the stability study data and certificate of analysis for three consecutive batches required in the checklist are generated under supervised, legal conditions.
However, Dr. G.L. Singhal, the former drug controller of Haryana, said many small companies lack the expensive machinery needed to run these tests.
“While big companies might comply, the rest of the industry may struggle to move past ‘paper compliance’ to make truly better drugs. The government has to ensure that compliance is being followed by the industry,” Singhal said.
Queries sent to the health ministry spokesperson and the DCGI office remained unanswered till the time of publishing.
