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(Set up by Ministry of Commerce & Industry, Govt. of India)

The Industry:
Indian Pharmaceutical Industry has made phenomenal progress over the years and made its impact in the global market. Indian Pharmaceutical industry has been recognized as reliable source for drugs and drug intermediates, pharmaceutical formulations. Tremendous opportunities are available for Indian Pharma industry in post 2005 era to manufacture and export many products getting off-patented. Its immense strength of manufacturing quality medicines at affordable prices made the Indian Pharma industry to compete both in regulated and non-regulated markets. This industry is playing a vital role in the Indian economy with 13.22 usd bn export turnover in the year 2011-12 with a growth rate of 23.34% and a CAGr of 16 % for past 5 years. Apart from its strengths in manufacturing and exporting allopathic medicines, India is known for its own systems of medicines with about 7000 units manufacturing various Indian system of medicines viz., Ayurveda, Unani, Siddha, Homeopathy etc. Fast growing Biotech industry, is a another part of Indian Pharma industry in India, which has great potential in the international market and which needs focused attention to improve its performance in the international market.

India in Alternative system of Medicine and Herbals:
India during the year 2011-12 (est. Val) has exported herbals & finished dosage forms belonging to the systems of Ayurveda, Homeopathy and Siddha USD 348 million with a growth of 16.5%.
UN Comtrade stats at six digit level, show, India during the calendar year 2010 has exported USD 790 million worth of Gums & Resins, Medicinal plants & Essential oils with a growth of 69% and is second largest exporter of that category next to China. India accounts for 10.4% of the total exports of this category.

Contract Research and Manufacturing:
Clinical research organizations (CROs) will increasingly look to India’s clinical trial sector. The reasons behind India’s attraction as a clinical trials destination are manifold. As a trade route junction for millennia, it has a large and genetically diverse population. Most of these people will be drug-naïve and are therefore perfect candidates for drug evaluation investigations. The Indian healthcare system has the necessary degree of integration to facilitate the clinical trial process and English is spoken extensively. Costs are very low, sometimes as much as 60% below the rates seen in developed countries. . India (CTRI) provides a welcome level of transparency that is not always evident in other emerging markets.

Salient Features of Indian Pharma Market:

India “The Pharmacy of the World”

  • Today, India is known to be termed “The Pharmacy of the World” as almost every molecule out of patent is manufactured in India with large vendor base.
  • Indian companies have filed highest number of DMFs during last 3 to 4 years. In yr. 2011, out of a total of 790 DMFs filed all over world, 400 were filed from India.
  • USFDA has granted 1024 market authorizations globally during 2011, out of which 324 has been granted to Indian companies.
  • More than 55% of formulation exports are to highly regulated markets endorsing Indian Industry`s adherence to highest standards of quality.
  • More than 25% of CEPS granted by EDQM are to Indian Companies, yet again endorsing Indian Manufacturing Practices. 
  • India is highest formulation exporter by volumes (2009 UN COMTRADE).
  • India is 14th largest exporter of Bulk Drugs + Formulation (Combined) in terms of value, holding a share of 1.57% (2010, UN COMTRADE).
  • Strong and Well developed Chemistry, R & D and Manufacturing Infrastructure.

Pharmaceuticals Export Promotion Council of India (Pharmexcil):
The dynamic growth of Indian Pharma Industry, a knowledge based industry, and the recommendations of four major Pharma associations made the Ministry of Commerce & Industry to realize the need for separate export promotion council. Accordingly, Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) has been set up on 12.5.2004. With its notification No.61 dated 16.3.2005; Director General of Foreign Trade made Pharmexcil the sole agency to issue RCMCs to all Pharma exporters.

About Pharmexcil:
Pharmaceuticals Export Promotion Council of India (Pharmexcil) is an export promotion council (EPC) for pharmaceutical industry in India promoted by Ministry of Commerce & Industry, Government of India to focus on healthcare and pharmaceutical products in the global arena.
Pharmexcil is mandated to help its members achieve excellence in export and facilitate overseas buyers to find suitable trade partners from Indian Pharma Industry.

Role of the Council:
  • Issue of RCMC
  • Organizing Trade delegations
  • Buyer-Seller Meetings at abroad
  • Organizing Reverse Buyer-Seller Meetings in India
  • Assisting members to get their MDA/MAI claims refunded from Govt. of India
  • Issue of Certificate of Origin Organizing periodical Seminars/Interactive meetings on exports related issues
  • Make suggestions to Govt. of India on policy issues relating to Pharma exports
  • Make representations to Govt. of India and other agencies in India and abroad to get amicable solutions for the common problems of the industry.
  • Organising seminars, workshops and awareness programs related to IPR & Regulatory Matters through Pharmexcil`s IPR & Regulatory Centre.

Categories under Pharmexcil:

  • Products and services falling under purview of our council includes:
  • Bulk Drugs and its intermediates
  • Formulations
  • Herbal
  • Ayurveda
  • Unani
  • Siddha
  • Homeopathic medicines
  • Biotech and biological products
  • Diagnostics
  • Surgical
  • Nutraceuticals
  • Collaborative research
  • Contract manufacturing
  • Clinical trials and Consultancy.
  • IPR & Regulatory Matters
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