The Indian Drug Manufacturers Association has alerted that the country would be witnessing in the coming years, continuous calls for technical harmonization based on US standards, tightening of product registration procedures in almost every country, raising of cGMP levels by the WHO agencies, expensive inspections from overseas regulatory agencies and various non-tariff barriers on pharmaceuticals to prevent competition from cost-effective countries like India. Speaking at the 41st annual day function of the Association, Dr. R.A. Mashelkar, Director General, CSIR and Secretary, Dept. of Scientific and Industrial Research, Government of India said that the country has to face these challenges with imagination and resourcefulness. Dr. Mashelkar was the chief guest at the function.

Dr. Mashelkar spoke on "Indian pharma in the new global setting: challenges and opportunities", and later presented the IDMA's top awards - Quality Excellence Awards, Research Awards and the GP Nair Best University Student Awards - at the annual day meet, and released the Association's 41st annual publication.

N H Israni, president, IDMA, in his Presidential address, highlighted the tremendous role played byDr Mashelkar in bringing a new perspective to the IPR issues, especially the interests of the poor and the underlining the need for a proper balance between pharmaceutical patent rights, public health requirements, local economic and technological development and the reduction of poverty in developing countries.

During his speech, Israni informed members that the Indian pharma industry would soon see the formation of its own focused export promotion council, Pharmexcil, which has been approved in principle by the Ministry of Chemicals & Fertilizers and the Ministry of Commerce and Industry. Pharmexcil - Pharma Export Promotion Council - will play an active role in building up India's image as a quality supplier of pharmaceutical materials and finished goods, Ayurvedic and Homeopathic materials and finished products, biotech products, neutraceuticals etc. It will also facilitate exports of knowledge-based specialized services. Pharmexcil is expected to be functional early next year and is the joint effort of the IDMA, OPPI, BDMA and IPA.

While speaking on the domestic industry, Mr. Israni expressed confidence about the increasing investments in R&D (which will touch about 3 per cent of sales this year), the expansion of production capacities, expanding employment opportunities for Indian scientists & technocrats, exciting initiatives in exports with many more facilities being approved by USA, UK & WHO and a new thrust in rural marketing and distribnmution efforts.

Israni said that the key areas of the future would be the options and opportunities afforded by the vast domestic market, improved R&D efforts, generic bulk drugs and intermediates, independent formulation exports, contract manufacturing of bulk drugs, formulations and nutraceuticals for MNCs, contract research including clinical and pre-clinical work, selective biotech R&D and production of cost-effective products such as anti-cancer products, vaccines etc.