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From a 100 per cent importer of medicines till the 1970s to the exporter of medicines to around 200 countries, including the developed markets like the US, EU, Japan, etc, the Indian pharmaceutical industry has indeed come a long way to adorn the epithet of 'the pharmacy of the world'. 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. But, unfortunately there is no exclusive central ministry for pharma and medical devices. The Covid-19 pandemic and more recently the US government’s imposition of 100 per cent tariff on pharmaceuticals have once again brought the Indian pharmaceutical and medical devices industries into limelight and has underscored the need to have an exclusive ministry for these two sectors to create an appropriate regulatory environment for the growth of these sectors. Presently, both these sectors are regulated by different ministries and agencies. While all the administrative and pricing related policies are regulated by the Ministry of Chemicals and 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 Ministry of Commerce and Industry. This multiple regulatory mechanism very often poses hurdles to the growth of these sectors to its full potential.
A separate central ministry exclusively for the pharmaceutical and medical device industry has been a long pending demand which the successive governments at the Centre have been paying little heed to. Ever since the present government came to power at Centre in 2014, there have been renewed talk of an exclusive Union ministry for pharmaceuticals and medical devices. The formation of a separate department, Department for Pharmaceuticals, for handling pricing related issues of these sectors in 2008 was a first step in this regard. But after that there was no move from the Central government to form an exclusive ministry for pharmaceuticals and medical devices for a long time. Eventually in the year 2015, it was the then Chemicals & Fertilizers Minister late Anant Kumar who set the ball rolling for the formation of a dedicated ministry for pharmaceuticals and medical devices. On more than one occasion, he had indicated that the Central government is seriously considering the formation of a dedicated ministry for pharmaceuticals and medical devices. In fact, the government had held discussions with different stakeholders on this issue. The matter was also brought to the notice of the Prime Minister’s Office and the PMO was reported to have convinced of such a need in the context of huge potential for growth in these two industry segments in the coming years. But since then, the Union government appears to have developed cold feet on the issue as there has been no visible movement from the government on the issue. There can be no two opinions about the growth potential of pharmaceuticals and medical devices sectors in the country. So, for the growth of these sectors to its full potential, an exclusive ministry at the Centre is the need of the hour.
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