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. Surprisingly, the pharmaceutical industry 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. 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. 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, an exclusive ministry is the need of the hour.
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 talks of a separate ministry for pharmaceuticals and medical devices. The then Union Minister for Chemicals & Fertilizers late Ananth Kumar himself had indicated on more than one occasion that the Central government is seriously considering to form a dedicated ministry for pharmaceuticals and medical devices. The minister had indicated about the move first in 2015 and then reiterated the same in 2017 and the government held discussions with different stakeholders. The matter was also brought to the notice of the Prime Minister’s Office and the PMO is 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. As the Indian pharmaceutical and medical devices industries are literally cruising to capture new heights, there is definitely an urgent need to create an appropriate regulatory environment for the growth of these sectors. The Covid-19 pandemic has 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.
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