Union government is keen to ensure India becomes a net exporter in active pharmaceutical ingredients (APIs) and intermediates on similar lines that of its success in generic formulations which is marketed to over 220 countries.
India has made a mark in the generic drug production space. From a net importer of drugs in the 70s, it now exports generic formulations to developed and developing countries. But in the area of raw materials for the production of these generic drugs, India needs to source from China and other countries. “We need to catch up with China and ensure self-sufficiency in this. Therefore the pharma industry should now gear up to prevent the over-dependence of APIs and intermediates from global majors”, said Dr VK Subburaj, secretary, department of pharmaceuticals, government of India.
A decade ago, we were dependent on China for 40 per cent of the APIs and now this has increased to 60 per cent. The government does not want to increase dependence any further and is working to ensure that the country can be self-sufficient in APIs, he added.
Now Indian pharma needs to maximize its production capability in APIs, said Dr Subburaj who was in Bengaluru for the Invest in Karnataka 2016 meet.
For this the government is creating a conducive environment for the pharma sector. From tax exemptions, to easing pollution control inspections among others, it is working to spur API or bulk drug manufacture extensively in India. It is already identifying areas for dedicated API Parks, he said.
The DoP secretary pointed out that there was a lot to learn from China to increase the volume of API production. The Pharma Parks in China spanned over 10,000 to 20,000 acres which enabled large scale manufacture. Therefore one move would be to ensure that the state government’s like Karnataka would need to increase their land allotment from 100 acres to 10,000 acres on similar lines that of Pharma Parks in China which spanned over such large areas.
Along with APIs, India needed to increase its efforts to manufacture phyto pharmaceuticals and Ayurveda. “We need to study the business model from China in this field too. There are over 100 large companies engaged in manufacture of Traditional Chinese Medicine as against India 5 or 6 big names in our Ayurveda industry. In phyto pharmaceuticals also Chinese have been diligent in high volume production and India needs to garner this expertise going by the wealth of medicinal plants here,” said Dr Subburaj.
In order to support the growth of pharma in India, regulatory infrastructure and its manpower needs a fillip. Currently, India has only 1,500 inspectors monitoring 15,000 pharma units and its 8 lakh pharmacy outlets in contrast to US where 15,000 regulatory officials supervise 3,000 units, he said.