Even though the Drug Controller General of India (DCGI) Dr M Venkateshwarlu's efforts to weed out irrational combination drugs from the market is facing legal wrangles, his efforts have not all gone waste as the doctors have started asking for clinical trial reports from the drug companies before prescribing such medicines.
According to industry sources, though doctors were so far kept away from the battle between the DCGI and the drug companies on the now infamous irrational combination drugs issue, several doctors have started asking for the clinical trial reports from the drug companies before prescribing such medicines, especially new products.
"This is a new development that will go a long way in weeding out irrational combination drugs from the market. When the marketing team approaches the doctors, they now also seek trial reports of the new drugs apart from other details", an industry source said.
Even when the FDC issue was raging in the country for the last more than six months, the doctors community were kept in dark about the developments both by the drug manufacturers and the drug department. This has resulted in a situation wherein doctors were prescribing the same irrational combinations which the drug authorities were trying to weed out from the market.
With the doctors asking for trial reports, the clinical trial industry in the country is booming with orders from the drug companies. An expert in the clinical trial industry and MD of a prominent company said that the clinical research organisations in the country are utilising their facilities to the capacities as orders are accumulating. Most of the orders are for BA/BE and stability studies. While it takes between 3 to 6 months for the BA/BE and stability study as per the international standards, it takes only one month for the study as per the Indian standards. For a BA/BE study it takes around Rs 6 lakh, the stability study costs around Rs 50,000, he said. "During the last some months, there is an increase of at least 100 per cent in the business, if not more", he added.