The Associated Chambers of Commerce and Industry of India (Assocham) has urged the Centre to increase the number of drug inspectors from existing 1000 to at least 3000 to ensure the quality of drugs in the country.
In a recent representation sent to the government, the ASSOCHAM president Sajjan Jindal has pointed out that current number of drug inspectors of around 1000 is totally inadequate to establish quality of drugs manufactured in the country.
The Director General of Health Services under Ministry of Health & Family Welfare in consultation with States Drugs Control Organisations should work out a mechanism so that the drug inspectors' number is increased to suggested levels of 3,000 to ensure that medicinal products are of acceptable quality.
This is necessary to make sure that commercial promotion of drugs is undertaken after their quality is totally verified, which is not possible with the drugs inspectors of around 1,000, he said. The Assocham has also stated that with limited number of drugs inspectors, pharma companies and their quality control cannot be safely subjected to inspections of existing standards, as a result manufacturing of fake drugs are mushrooming.
As regards, approvals for conducting clinical trials, India takes a minimum of eight months to accord clinical trials approvals whereas in countries like Canada, UK, USA and Netherlands, such approval are accorded in a month's time, he said, seeking intervention of the prime minister to direct the concerned authorities to speed up the process of approvals.
"In India, the pharmaceutical companies are subjected to different procedures for obtaining permissions for clinical trials which take a minimum of 8 months time. This anomaly needs to be corrected as domestic pharma companies spend thousand of crore of rupees on R&D to come out with innovative medicines and life saving drugs, the clinical trial of which takes longer. In the meanwhile, they lose on patenting their discoveries," an Assocham release said.
The Assocham note also pointed out that longer time is taken for obtaining clinical approvals as domestic pharma companies are subjected to long bureaucratic processes in Health Ministry and other relevant departments which delay the clinical trials. Its serious implication is that the competitors of domestic pharmaceutical industries take advantage as it is difficult to keep pharmaceutical innovations confidential.
"The Chamber is of the view that Indian pharmaceutical industry is facing major hurdles to its growth both within India and globally. Undue regulatory pressure is further frustrating the domestic pharma to such an extent that if immediate corrective measures are not taken, many life savings drugs are likely to go out of production. It is ironic that the Indian industry which was encouraged in 1991 to meet global challenge, is today being held back from growth by our own archaic, short-sighted policies and red tape," it said.