Patients turn guinea pigs

Hyderabad, Dec. 7: Hyderabad is now becoming a hub for drug trials with local clinical research organisations (CROs) and hospitals tying up with the international pharmaceutical companies. According to sources, drug trials are practised in government hospitals including the Gandhi Hospital here. There is no system to regularly monitor the drug research in the country and in the state, the authorities added.

The "volunteers" are brought from labour addas in the city as well as from the people migrating from districts like Srikakulam and Mahbubnagar. A senior drug administration official said, "In developed countries, there are stringent provision for drug tests. Its cost is much higher there than in India. Thus, they are outsourcing CROs to countries like India. There are around 10 to 12 clinical research organisations here that are conducting drug trials. Most of the "volunteers" accept this for a monetary sum of at least Rs 1000 per day. However, they get their wages for only Rs 200."

The "volunteers" must be informed about the consequences in Telugu through writing. "This is not happening in few places. The poor patients in the hospitals and CROs are made as guinea pigs. Few companies do not follow any ethics. Several pharma companies have their own CROs now," said the senior drug administration official.

The All India Drug Control Officers Federation general secretary, Mr R. Uday Bhaskar, said, "Clinical research has to be regularised in India. The state drug control administration has to be given powers to regulate the drug trials. The administration has no powers to regulate the clinical trials now.

"It is estimated that in the next 10 years, major part of clinical research will take place in India. For the past two years, the state has developed a system where a CRO conducting a drug trial informs the Drug Controller General of India who sends an official to inspect it. There should be regular and close monitoring on the drug trials," said Mr Bhaskar.

The Gandhi Hospital superintendent, Dr B. Balaraju, said, "We are allowing drug trials after the clearance of ethics committee of the hospital. These drugs are approved by the Drug Control General of India. Recently a cancer drug research took place. There are no problems here. Even students do research studies here."

The director of Medical Education, Dr Sudha Ramana, said, "All the major hospitals are doing drug research. The Director of Medical Education has no role. It is the hospital ethics committee that looks into the matter."

The officials said that the drug research in Hyderabad are of Phase-2 and Phase-3 type. The Drug Controller General of India has stated that Phase-1 clinical research unless manufactured indigenously will not be permitted. A CRO official said, "It is a huge business. India should give up the guinea pig syndrome and encourage clinical research. There are strict guidelines for this."