Emerging clinical research industry in India is facing the threat of a mushrooming of operators in the name of contract research organizations according to M Venkateswarulu, Drug Controller General of India.

Such operators with no ethical norms and concerns can seriously damage the reputation of this nascent industry in the country, he said while speaking a conference on "Drug Discovery and Clinical Development in India: Opportunities and Challenges," organized by Drug Information Association (DIA) here today.

This is an area of concern for the government and regulatory bodies in India today. The Central government has commenced work to establish a specific regulatory authority for clinical research and the amended rules under Schedule Y of the Drugs & Cosmetics Act have been already notified for the purpose, he said.

Apart from the regulatory control on clinical research, CROs themselves should evolve a code of conduct for the members in the interest of their own existence. Otherwise the industry could face the prospects of doom before it takes off, Venkateswarulu said.

Earlier speaking on "Role of Preclinical Safety Testing in Clinical Development of Drugs," David Jacobson-Kram, head of Pharmacology and Toxicology, CDER, US FDA, said that filing of new drug applications is becoming fewer with US FDA as the failure rate of drug candidates is rising. Approval rate of new drugs by the US FDA has come drastically in 2003.

High concerns of toxicities and other safety considerations of new drugs are forcing pharmaceutical companies in the US and other drug producing countries to drop drug candidates at pre clinical and clinical phases. One major reason is the carcinogenicity studies on human for increasing number of drug compounds involving two to three years.

This is a highly expensive process for the pharma companies. Use of animal models for carcinogenicity studies in future can bring down the costs and the duration of such trials in future, Jacobson-Kram said.

Ramana Sonty, Life Sciences Industry Management Consultant, PRTM said that as the global pharmaceutical industry is heading for a structural change with very few big players and a large number of mid size and small players. This trend is well illustrated by shrunk sales of world's largest pharmaceutical company, Pfizer, at 8 per cent last year from 11 per cent just two years ago.

The pharmaceutical industry should therefore go for an integrated cross functional approach to survive in this market scenario. An appropriate therapeutic area strategy need to be adopted for this.

For medium and small pharmaceutical units partnering or co development approach in therapeutic area could be ideal considering their relatively weak financial strength, Sonty suggested.