Clinical trials move cheers drug firms

Mumbai, New Delhi, Hyderabad

The Centre’s notification amending Schedule Y of the Drugs & Cosmetics Act is expected to open floodgates for multinational drug companies to tap India’s large resources for clinical trials. The schedule refers to clinical trials in India.

According to analysts tracking the sector, it is really “India Advantage” because the country offers a huge population with a diversity of diseases that are untreated. The director general of the Organisation of Pharmaceutical Producers’ of India (OPPI), the apex body of MNC pharma firms in India, Dr Ajit Dangi said, “The government’s move is in the right direction. The amendment is in compliance with the IPR guidelines. However, the major issue is data protection. How the government is going to protect the data provided by MNCs is more crucial.”

According to Dabur Research Foundation R&D head Dr Rama Mukherjee, the move to bring in new rules for conducting clinical trials in the country is a good thing for the pharmaceutical and biotech firms engaged in research activity. “Till date, we have not contributed a single drug in the global arena. Firms will now be able to carry out phase II and phase III trials here simultaneously with global trials,” she pointed out.

The contract business in the country doubled in 2004 to Rs 275 crore and the current outsourced clinical trial activity in India is at Rs 350 crore. The opinions from overseas also look optimistic. “I personally feel clinical research is all set to get a major fillip with the new government’s directive. Every drug used for diagnostic, preventive or therapeutic purpose undergoes a long and rigorous testing process spread over a 10-15 year period,” says Dr Vijay Kumar, who is president of the US-based clinical research firm Neeman Medical International.

Ernst & Young India’s head of healthscience practice, Utkarsh Palnitkar said, “I look at these steps as intermediary in nature. Ambiguities still remain as far regulation is concerned in clinical development of a drug here. The floodgates will really open when phase I trials on humans is permitted.” Access to modern drugs is the key here. As Shanta Biotechnics, CMD, Varaparasad Reddy puts it, “The present decision by the government to allow multi-centric phase II and III trials by MNCs will give the country access to it.”

— Financial Express