The recent initiatives taken by Indian Government in the field of drug regulatory affairs are aimed to make the industry at par with contemporary world class standards with a view to make India emerge as one among three major drug manufacturing countries in the world by 2020, said Ashwini Kumar, Drug Controller General of India (DCGI).

In his inaugural address at the ISPE India 2005 annual conference today in Mumbai, the DCGI said efforts are to create a world class regulatory system in the country and to ensure drugs are produced with acceptable quality, preventing unsafe drug production practices. The country has brought in newer benchmarks of contemporary standards to produce drugs with safety, efficacy and quality. Enough time has been given for manufacturers to comply with revised Schedule M requirements.

Efforts are on to streamline the many decade old licensing norms of medical shops and manufacturing units. The national pharmacovigilance programme is being implemented to monitor the safety profile of drugs in the market. The Indian Pharmacopoeia Commission has now become a reality and its governing body has been constituted. Emerging areas like stem cells and recombinant products need to have a regulatory environment and the Government is studying these areas. The aim of the Indian drug industry should be to create India brand in the global markets, said the DCGI.

Bob Best, president ISPE said the Society is growing as the most important organization of pharmaceutical engineers worldwide. Now it has 23,000 odd members in 81 countries and is actively engaged in improving the knowledge base of its members, information exchange and technical documentation. Joint education programmes are conducted in association with FDA and academia. A new scientific journal is being launched to better inform the professionals. A professional certification programme manufacturing professional of the future (PMPF) and Chartered Pharmaceutical Profession (ChPP) has been started by the Society. Facility of the year award for 2004 was given to Novo Nordisk of Denmark, said Bob Best. He presented 2004 affiliate of the year award to ISPE India and Ajith Singh, Chairman, ISPE India was awarded member of the year award.

Habil Khorakhiwala, chairman, Wockhardt in his key note address said simultaneous multi-country drug launches, improved sales force, direct to consumer promotion etc., are some of the key areas Indian pharma companies have to concentrate in future. The size of the global drug industry is estimated to be in the region of 950 to 1300 billion dollars by 2020 and India should be able to corner a substantial share of this market. India is emerging as a major hub for research and numerous Indian R&D professionals working abroad are now willing to work in Indian environment, causing a reverse brain drain. Shift from chemicals to biotech products is an emerging trend as shorter commercialization period, less ADR etc are its advantages. About 47 per cent of the NCEs are biotech products, and 11 biotech patents are expiring by 2006. Now six products corner 80 per cent of the biotech drug market. Of this, India has four products. US and EU regulatory agencies are moving towards allowing biogeneric products in those countries, said Habil Korakiwala.

Ajit Singh, chairman, ISPE India elaborated the functions of ISPE India. He said ISPE India board of directors has been formed and is planning to start a publication for the members. Though just 18 months old, the Society has grown to over 500 members. Various programmes have been planned by ISPE India to help its members, and discounts are offered on membership fee to enroll more technically oriented industry professionals, said Ajit Singh.

Gopal Nair, vice chairman, ISPE India proposed a vote of thanks. The two day conference is attended by about 100 professionals from various companies and the eminent speakers include Joe Phillips, former USFDA official and Advisor to ISPE on regulatory affairs, Bob Tribe, ex-TGA Australia etc.