The Union Minister for Chemicals and Fertilizers, Ananth Kumar last week stated in Bengaluru 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 has been under discussion with different stakeholders. Now the matter has been already brought to the notice of the Prime Minister’s Office and the PMO is also 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. India’s pharmaceutical industry has grown into a major sector over the last 30 years having an annual production in excess of Rs. 2 lakh crore with as much as 50 per cent of that being exported to over 150 countries including to most of the developed nations. The country has over 10,000 pharmaceutical units and 7 lakh trading establishments in the retail and wholesale segments. And over the years, India has earned the name as the only major supplier of quality generic drugs at lower prices to the world. This is certainly a great achievement for a sector which was dominated by the multinational drug companies until seventies. The medical devices industry is another sector which is showing great potential for growth in India considering huge demand for these products in the country. Here also, market for these products is currently dominated by multinational companies with Indian companies producing only 30 per cent of country’s requirement. The need to place this industry in a conducive industrial environment has been under discussion amongst the industry leaders and the concerned government officials for some time in the context of the growth prospects of this sector. The government decision to have a separate department for handling pricing related issues of this sector in July 2008 was a first step in this regard. Until then, the secretary in charge of department of chemicals and petrochemicals, has been looking after the affairs of the pharmaceuticals.

Considering the size of Indian population and the growing healthcare needs of the country in the coming years, there is a need for creating an appropriate regulatory environment for the growth of these sectors. Currently, regulatory issues of these sectors are decided by different ministries and agencies and that often pose hurdles to their growth. The pricing policy is decided by the ministry of chemicals and fertilizers, manufacturing and quality control is under the control of the health ministry, investment policy and IPR matters are handled by the industry ministry and the export related policy is decided by the commerce ministry. The move to form an exclusive ministry for the development of these two industry segments was under discussion amongst the industry leaders and the government officials for some time. The government decision to set up a separate department for pharmaceuticals handling pricing related issues in July 2008 was the first step in this regard. Until then, the secretary in charge of department of chemicals and petrochemicals, has been looking after the affairs of the pharmaceuticals. The Central health ministry is currently the regulatory body for sectors like pharmaceuticals, food and hospitals. The commerce and industry ministries are looking after policies relating to all industries, exports, patents and trade marks. Therefore, a ministry for pharmaceuticals and devices with powers to decide these divergent policy matters and regulatory issues of these two segments is going to be a tough exercise and that may probably need detailed inter ministerial discussions.