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Ramesh Shankar
Wednesday, September 21, 2022, 08:00 Hrs  [IST]

The Department-Related Parliamentary Committee for the Union Ministry of Health and Family Welfare has recently recommended to the Central government to bring the Department of Pharmaceuticals (DoP) under the Union Ministry of Health for better coordination between the industry and the government. At present, the DoP is a separate department under the Union Ministry of Chemicals & Fertilizers. 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, in its report on ‘Medical Devices: Regulation & Control’ felt that the mandate of the DoP is very much related to the health sector like drugs and medical devices, their production, development, control, promotion, education, and training & research. Hence, the Committee strongly felt that, for better coordination, the DoP should be brought under the Ministry of Health & Family Welfare from the Ministry of Chemicals & Fertilizers. So, the Committee recommended to the government 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.

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. From a mere Rs.10 crore in 1948 to more than Rs. 2 lakh crore at present, the Indian pharmaceutical industry has undisputedly grown by leaps and bounds. Indeed, it has come a long way to adorn the epithet of 'the pharmacy of the world', exporting affordable quality medicines to more than 200 countries in the world, including the developed countries like the US and Europe. Of course, it is a great feat for a sector which was dominated by the multinational drug companies until 1970's. More importantly, the leapfrog jump of the Indian pharmaceutical industry, and of late that of the medical devices industry, is continuing as the industry since then did not look back and, in fact, it is literally cruising to capture new heights. 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. There can be no two opinions about the growth potential of pharmaceutical and medical devices industries in the country. So, for the growth of these sectors to its full potential, the government should pay heed to the recommendations of the Parliamentary Committee in letter and spirit.


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