Should DoP be brought under health ministry?
There can be no two opinions about the growth potential of pharmaceutical and medical devices industries in the country. However, the industry is now regulated by multiple agencies
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It is obvious that since the Ministry of Health and Family Welfare is the key stakeholder and the medical devices being very diverse in range with respect to technology and material sciences, inter-ministry coordination is required between various departments, which should be done by the Ministry of Health and Family Welfare only, and not the Ministry of Chemicals & Fertilizers
A Parliamentary panel has recently recommended to the Central government to bring the Department of Pharmaceuticals (DoP) under the Union Ministry of Health and Family Welfare for better coordination between the government and the industry on several regulatory issues concerning the industry. At present, the DoP is a separate department under the Union Ministry of Chemicals & Fertilizers. The Department-Related Parliamentary Committee for the Union Ministry of Health and Family Welfare, which looked into the medical devices regulations and recommend the way forward, asked the Central government to bring the DoP under the Health Ministry for better coordination and also pitched an idea of setting up an exclusive Department of Medical Devices. The Committee, in its report on 'Medical Devices: Regulation & Control', opined that the Covid-19 pandemic has highlighted the need to support indigenous manufacturers of medical devices. The pandemic laid bare various issues like insufficient infrastructure and fund for research and development, lack of public funding for research, dearth of skilled manpower, lack of synergy between Central-State regulatory authorities, inappropriate regulations for medical devices, lack of global-level quality standards, etc plaguing the medical device industry in India. The Committee recommended that separate legislation exclusively for the Medical Devices and bringing the DoP under the Ministry of Health and Family Welfare would really help solve some of the major challenges being faced by the medical device manufacturers in the country.
It is a fact that the DoP was created in the year 2008 with the objective to give greater focus and thrust on the development of pharmaceutical sector in the country. Besides, by creating a separate department, the government wanted to regulate various complex issues related to pricing and availability of medicines at affordable prices, research & development, protection of intellectual property rights and international commitments related to pharmaceutical sector which required integration of work with other ministries.
On the other hand, the issues related to quality of the drugs produced and marketed in the country are regulated by the Union Health Ministry. The Parliamentary Committee felt that the mandate of the Department of Pharmaceuticals is very much related to the health sector like drugs & medical devices, their production, development, control, promotion, education, training & research. Hence, the Committee strongly felt that, for better coordination, the DoP should be brought along with Department of Health and Family Welfare under the Ministry of Health & Family Welfare from the Ministry of Chemicals & Fertilizers by amending the Government of India (Allocation of Business) Rules, 1961.
It is obvious that since the Ministry of Health and Family Welfare is the key stakeholder and the medical devices being very diverse in range with respect to technology and material sciences, inter-ministry coordination is required between various departments, which should be done by the Ministry of Health and Family Welfare only, and not the Ministry of Chemicals & Fertilizers. There can be no two opinions about the growth potential of pharmaceutical and medical devices industries in the country. However, the industry is now regulated by multiple agencies.
While all the administrative and pricing related policies are regulated by the Ministry of Chemicals & Fertilizers, the issues related to quality of the drugs produced and marketed in the country are regulated by the Union Health Ministry. Policies related to investment and IPR as well as that of exports are regulated by the Union Ministry of Commerce and Industry.
This multiple regulatory mechanism very often poses hurdles to the growth of these sectors to its full potential. It is a fact that the pharmaceutical industry, including the medical devices sector, in the country achieved the current global status without having an ideal policy and regulatory environment on account of the fact that the industry is being controlled by different ministries and agencies. The Parliamentary panel has rightly identified the issue and has accordingly recommended to the Central government to bring the DoP under the Union Ministry of Health and Family Welfare for better coordination between the government and the industry.
(The author is freelance journalist with varied experience in different fields)
