DCGI sub-committee drafts document guidance on formulation development as per WHO guidelines

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With unanimous agreement by all members, the sub-committee, constituted by the DCGI last year on development of guidelines on formulation development for Indian pharma, has drafted the report by adopting the guidelines of the World Health Organisation on food and drugs.

The nine-member committee chaired by the Punjab drugs controller handed over the report to the DCGI for further action.

The members of the committee felt that the WHO guidelines were closest to practical situations in India, so it could be replicated in our country where multi-source drug products (MDPs) are in wide circulation. Such products are manufactured here largely by small, medium and big pharmaceutical companies.

The report, a copy of which was reviewed by Pharmabiz, says that a healthy ‘quality management system’ (QMS) is required as part of the Indian regulatory frame work to manufacture consistent quality drugs. This is with the intention that government wants to introduce strong policy measures to increase the quality of the drugs manufactured and distributed in the country. As per the report, the national and state regulatory authorities desire that there should be minimum self explanatory guidelines under the Drugs & Cosmetics Rules which will advise the manufacturers and guide the regulators to establish safety and efficacy of each formulation manufactured in a facility.

If the report is approved by the government, the manufacturers will have to produce all documents concerning procurement and possession of the raw materials they require for the purpose of development of proposed formulations. For this, it is recommended that the word ‘development’ has to be inserted prior to ‘examination test or analysis’, in Form 29 of the D&C Rules. Similarly, the facility for the purpose of product development has to be owned or outsourced to third party contract research organisation which should have a valid license in Form 29 issued by the competent licensing authority.

The draft guidelines mandate that for the purpose of development of drug formulations covered under the definition of new drug as defined u/r 122 E(a), license in Form 29 is required to be issued by the SLA on the basis of NOC issued by the DCGI. Whereas in the case of new drugs covered u/r 122E (b) & (c), the licenses in Form 29 should be issued by SLA, except clinical trial studies under Schedule Y. Manufacturing facilities complying GMP norms and holding licenses in Form 25 and in Form 28, the F&D pilot scale facility provided in such manufacturing units, need to follow the GMP norms as provided under revised Schedule M.

As per needs of the industry, provisions may be made to permit in-licensing and technology transfer of formulation and development techniques along with data from innovator/developer holding license in Form 29. DCGI will prepare a consolidated list of comparator products and make it available on website for reference of the stake holders. Further, the draft guidelines recommend that the concept of retest period should be introduced for APIs, definition of ‘generic product’ needs to be introduced in the D&C Rules, and overages requirements/limits in Schedule V and in IP in the monograph of each drug need to be mentioned.

Referring to the report, the chairman of the nine-member sub-committee, said the guidelines will help the manufacturing industry to design and develop quality products, further to validate their manufacturing and testing processes for the purpose of consistent delivery of the intended performances of the products.

Pardeep Kumar Mattu, chairman of the committee and drugs controller of Punjab, said, while drafting the guidelines the members considered issues related to regulations regarding quality, safety and efficacy of the drugs manufactured and marketed in India. Secondly, the committee felt that minimum scientific studies are required for the manufacturer to design, develop and stabilize the product throughout its life cycle. Similarly, a legal frame work is also needed for uniform implementation of food and drug guidelines.

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