Government amending Drugs and Cosmetics Act: J P Nadda

Rohit Taneja

India's life sciences industry is the third-largest contributor to reducing the country's merchandise trade deficit. The industry now generates around USD 10 billion of trade surplus every year, allowing it to neutralise around 4 to 5 per cent of total energy imports for India.

It has the potential to become USD 200 billion industry and ramp up its trade balance contribution by five times to create trade surplus of about USD 55-60 billion for the country. This would also neutralise 13-15% of energy imports for the country from the current 4-5%.

The FICCI report titled 'Indian life sciences: Vision 2030 - Expanding global relevance and driving domestic access' states the above and was released by Union Minister for Health and Family Welfare, J P Nadda at the FICCI Life Sciences Conference 2015 on the theme 'Pharma Vision 2030: Building India's Global Relevance' in New Delhi. The conference was attended by government officials and leaders of the industry.

According to a FICCI release, JP Nadda informed that the government was in the process of amending the Drugs and Cosmetics Act to unleash innovation and the entrepreneurial spirit of manufacturers and ensure the rights, safety and well-being of clinical trial participants, while at the same time facilitating such trials.

Speaking about research and development (R&D), he said that Indian pharma companies were spending less than 2% of their total turnover on (R&D). Having established itself in pharmaceutical manufacturing, it is time the Indian life sciences industry focus on the development of new molecules and innovations. The window period of 2015-18 is very critical when the patent tenure of many biopharmaceuticals and innovative molecules will expire. The Indian manufacturers can leverage this opportunity.

Jyotsna Suri, President, FICCI, said that the sector was facing challenges, like the changing market and business dynamics, pressure on pricing and margins, regulatory hurdles and growing dependence on China for intermediates. The sector looks to the government for support. If successful the sector would contribute to the healthcare and economy both for India and the world. It would also create about 4 million additional jobs over the next 15 years.

Dr. Habil Khorakiwala, Chairman, FICCI Life Sciences Council, Past President, FICCI and Founder Chairman, Wockhardt Group, informed, "The industry has been a flag-bearer for access and affordability across the world by being the primary supplier of essential medications for numerous diseases and in reducing healthcare costs considerably. Envisioning the potential that this sector offers, FICCI Life Sciences Council decided to come up with this vision document with Mckinsey & Company as the Knowledge Partner." He added that R&D is the key for success of 'Make in India' campaign and urged the government to support private industry's R&D and innovation initiatives by helping with funding for such programmes.

Aligned to PM's 'Make in India' Mission, the FICCI report suggests 10 potential initiatives for the industry and government to help achieve the above vision:

         Drive innovation at scale by making 'smart' portfolio choices, strengthening capabilities and revamping operating model

         Expand presence in emerging markets through focussed approach and by building a ' global' supply chain and organisation

         Adopt innovative business models to deepen penetration and drive access in rural India as well

         Upgrade quality systems, infrastructure and enhance capabilities to maintain India's image of reliable, high quality supplier

         Build new-age capabilities to sustain cost and speed to market advantage

         Collaborate more meaningfully within the industry to support growth and industry evolution

The government, on its part, will need to support this journey by creating a conducive environment for the industry to undertake the above actions.

         Build an enabling regulatory environment to facilitate "ease of doing business"

         Help improve quality standards by strengthening  pool of inspectors and harmonising with global guidelines

         Ensure India's self-sufficiency by helping competitiveness of local API industry

         Create conducive environment for innovation

Dr. Surinder Kher, Managing Director, Ecron Acunova, said that the regulatory system needs dynamism and assured that the industry would support the government's endeavour to strengthen the policy framework in the country. He added that the recommendations that would emerge from the conference would be shared in detail with the government for consideration.  

AuthorRohit Taneja
Date06 June, 2015


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