Law Firm For Pharmaceutical Sector In India

The Union Cabinet has given its nod for the amendment of the existing Foreign Direct Investment (FDI) policy in the pharmaceutical sector in order to allow FDI up to 100 per cent under the automatic route for manufacturing of medical devices subject to certain conditions.

The drugs and pharmaceuticals sector attracted cumulative FDI inflows worth US$ 13.32 billion between April 2000 and September 2015, according to data released by the Department of Industrial Policy and Promotion (DIPP).

Oflate , major investments have had been seen in the Indian pharmaceutical sector by prominent players like Cipla, Glaxosmithkline, Lupin , Strides Arcolab, Cadila Healthcare , Torrent , SRF , Intas Pharmaceuticals etc.

Government Initiatives so far in India 

The Addendum 2015 of the Indian Pharmacopoeia (IP) 2014, published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, will result in enhancement of the quality of medicines that would in turn promote public health and accelerate the growth and development of pharmaceutical sector.

The Government of India(GOI)  unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments.

The Government of India has also introduced the folowing mechanisms such as

a.  Drug Price Control Order and

b. National Pharmaceutical Pricing Authority

to deal with the issue of affordability and availability of medicines.

Some of the major initiatives taken by the government to promote the pharmaceutical sector in India are as follows:

• The GOI plans to incentivise bulk drug manufacturers, including both state-run and private companies, to encourage ‘Make in India’ programme and reduce dependence on imports of active pharmaceutical ingredients (API), nearly 85 per cent of which come from China.
• The Department of Pharmaceuticals has set up an inter-ministerial co-ordination committee, which would periodically review, coordinate and facilitate the resolution of the issues and constraints faced by the Indian pharmaceutical companies.
• The Department of Pharmaceuticals has planned to launch a venture capital fund of Rs 1,000 crore (US$ 154 million) to support start-ups in the research and development in the pharmaceutical and biotech industry.
• Indian and global companies have expressed 175 investment intentions worth Rs 1,000 crore (US$ 150 million) in the pharmaceutical sector of Gujarat. The memorandums of understanding (MoUs) would be signed during the Vibrant Gujarat Summit.
• Telangana has proposed to set up India’s largest integrated pharmaceutical city spread over 11,000 acres near Hyderabad, complete with effluent treatment plants and a township for employees, in a bid to attract investment of Rs 30,000 crore (US$ 4.5 billion) in phases. Hyderabad, which is known as the bulk drug capital of India, accounts for nearly a fifth of India’s exports of drugs, which stood at Rs 95,000 crore (US$ 14.3 billion) in 2014-15.
• At the launch of Cluster Development Programme of pharmaceutical sector, Mr Ananth Kumar, Minister of Fertiliser and Chemicals, announced that six pharmaceutical parks will be approved and established this year which will have sufficient infrastructure and facilities for testing and treatment of drugs and also for imparting training to industry professionals.

Road Ahead

The Indian pharmaceutical market size is expected to grow to US$ 100 billion by 2025, due to  increasing consumer spending power, rapid urbanisation, and raising healthcare insurance among others.

Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.

The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programmes, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies..

References: i) Consolidated FDI Policy, Department of Industrial Policy & Promotion (DIPP), Press Information Bureau (PIB), Media Reports, Pharmaceuticals Export Promotion Council

Source : http://indiainbusiness.nic.in/

AMLEGALS , a full service law firm advises & handle litigation, in India ,  for pharmaceutical busines houses of India & those companies which are from China, UK, USA, Singapore,UAE , Japan, Italy, Russia, etc . We have expertisee in  Pharmaceutical Industry .