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Govt to bring new guidance document to ensure uniform rules for R&D
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Arun Sreenivasan, New Delhi
September 27 , 2018
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The Central Drugs Standard Control Organisation (CDSCO) will soon come out with a comprehensive guidance document to ensure uniform regulatory requirements for drug research and development across the country, a move that will fast-track licensing procedures and promote ease of doing business. The decision to bring out the new guidelines was taken at a recent meeting of the Drug Consultative Committee (DCC) and an expert panel constituted by the Drugs Controller General of India is working on it, it is learnt.
According to industry sources, the DCC, an advisory body to secure uniformity throughout India in the administration of the Drugs and Cosmetics Act, has weighed various measures to improve the quality of pharmaceutical formulations, such as making requirement of Form 29 mandatory for granting manufacturing licence and tightening existing regulations for developmental studies. Form 29 is a licence to manufacture drugs for the purpose of examination testing and analysis.
The sub-committee to prepare the guidance paper is headed by the Punjab drug controller and includes drug controllers of Haryana and Telangana, deputy drug controller at CDSCO east zone Dr A Ramkishan, former director of LM College of Pharmacy Mukesh C Goel and two formulation R&D experts.
The new guidelines in the works are expected to further elaborate on developmental study requirements including safety and compatibility of excipients, process and analytical method validation, impurity profiling of active pharmaceutical ingredients and bioequivalence (BE) and bioavailability (BA) reports, industry sources say.
It may be noted that the national drug regulator has recently issued a draft guidance paper on the approval process for BA/BE studies with human participants in India for export purposes. BE studies, conducted to establish that two medicines work the same way and are interchangeable, is crucial for ensuring the safety and tolerability of generics against corresponding innovator drugs.
The government has been looking for ways to avoid dual standards of quality in the pharmaceutical sector and is all set to join the Pharmaceutical Inspection Cooperation Scheme (PICS) to implement a uniform inspection standard. The PICS is a global mechanism to boost cooperation in good manufacturing practices between countries and regulatory authorities.
Lack of uniformity in rules often hits domestic pharmaceutical manufacturers hard as firms struggle to comply with legal requirements that tell them to do one thing on the one hand and the opposite on the other. Last year, Bihar state licensing authority abruptly banned the production and sale of levofloxacin and ofloxacin for paediatric use in the state while the same formulation was marketed freely in other states. Drug manufacturers were forced to move Patna High Court against the unanticipated action as stock worth around Rs.60 lakh were lying in manufacturers’ godowns when the ban was imposed. The court later quashed the drug controller’s directive.
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