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The implementation of the latest Pharmaceutical Policy which is now in its draft stage requires a strong and single department known as Indian Drugs Administration (IDA) which will deal with all major issues related to quality, patenting, pricing of drugs, cosmetics & medical devices, etc, said Dr. BR Jagashetty, former National Adviser (Drugs Control) to MoHFW and CDSCO and former Karnataka state drugs controller.
Early this year, while the government was considering to rename ‘CDSCO’ as ‘Indian Drugs Administration and review the functions of the Drugs Controller General of India (DCGI), there is also need to redraft or rewrite a fresh Drugs and Cosmetics Act and Rules incorporating a separate chapter for pricing, registering brands, patent issues and fixing the responsibility for marketers who may be treated on par with manufacturer, he added.
It is very much necessary to enable appropriate control over State Licensing Authorities especially with respect to granting permissions and approvals for various drug formulations including FDCs (fixed dose combinations), said Dr. Jagashetty.
India is at the centrestage for production of pharmaceuticals being third largest by volume and 14th in terms of value. Therefore, it needs to be in a commanding position globally. This is where the Indian Drug Administration is seen as appropriate in the milieu of Digital India, Make in India, Uniform Code Pharmaceutical Marketing Practices (UCPMP), medical devices policy and price monitoring cells. Furthermore, significant developments like the patent expiry era, entry of new drug formulations, novel biologicals and biosimilars along with advanced drug delivery devices like disposable injectable pens, skin patches and inhalers, will require qualified and experienced enforcement personnel to inspect and approve a range of drugs.
This will automatically take the pharmacy education and the existing professionals to a next level of growth. With information technology now driving much of the online license issue and approval, the government may see the need for separate team of highly qualified and experienced personnel to work for the regulatory service.
The IDA would be able to give Indian regulatory services to be recognized nationally & internationally. It will need to operate and serve the pharma industry on similar lines that of the US FDA and EMA. There will be need to address regulations and come out with revisions to obsolete drug laws, he said.
To head IDA, the government will need to consider creating dedicated exams like the Indian Drug Services (IDS) through UPSC. Such a system would create a proper hierarchy and bring in a systematic reporting structure which will be uniform to both Center and State, where the format may be similar to the Indian Administrative Service (IAS), Indian Police Service (IPS) and Indian Forest Service (IFS). The position would exercise focused drug administration including framing and implementation of policy in consultation with preferably a single ministry instead of multiple ministries, said Dr. Jagashetty.
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