A section of pharma industry may soon move Delhi high court against the drug procurement agency RITES's recent decision in which the agency had made it mandatory for the pharma companies to have WHO-GMP Certificate for participating in their tenders for procuring drugs for supplying them for the government-run hospitals in the country.
Sources said that the industry is making efforts to convince the RITES authorities that its decision in this regard is in violation of directives of DCGI and the prevalent law. The industry has termed the action of RITES and some state governments as illegal. Quoting the drug controller general of India's (DCGI) letter dated March 1, 2004, the industry said that it has been made clear to State Licensing Authorities that WHO-GMP Certificates and COPP shall be issued only in case of export of drug and not for supplying drugs in India.
"We have approached the RITES authorities in this regard and they have said that the request will be considered. But, it is a verbal assurance and nothing has come in writing. If the issue is not resolved in a day or two, we will move Delhi high court", an industry leader said.
RITES in its latest tender notification has made it a precondition that the drug companies which possess the WHO-GMP Certification can only participate in its tenders for procuring drugs for supplying them for different central government hospitals. The central government had some time back appointed RITES as the agency for procuring drugs at competitive rates from the private drug manufacturers to supply the them in the government-run CGHS dispensaries and other hospitals.
Apart from RITES, some state governments like Jharkhand have also made it mandatory to have WHO-GMP Certification for participating in the government tenders for procuring drugs for the state-government run hospitals.
After enhancing the turnover criterion to astronomical levels from Rs 3 crore to Rs 35-50 crore, the latest decision of RITES and some state governments will virtually disqualify the small pharma companies from participating in the government tenders.