Small drug units are up in arms against the stipulation of most of the government agencies insisting on a WHO GMP certification for being qualified to participate in government tenders. They are terming the stipulation as illegal and discriminatory.
As CDSCO has made it mandatory that drug units obtaining an export order should have a WHO GMP certification but this condition is not applicable to domestic suppliers of drugs, asserts the sources from drug SSI sector.
Supporting this view of the SSI sector, senior officials in the CDSCO, the manufacturing license and drug license issued by a competent authority as per the respective provisions of Drugs & Cosmetics Act, automatically qualifies the drug manufacturers to participate in the purchase tenders floated by local institutions and government bodies.
Moreover, according to the current practice, the drug control department shall not consider the applications submitted by the drug companies for WHO GMP inspection unless it is supported with an export order. Though the officials admit that this provision causes a lot of inconveniences for the exporting companies as they can seek the certification only after securing the order first time, it helps the department to eliminate the unnecessary applications.
However, it is in the discretion of the state or central drug control departments to evaluate the genuineness of the applicant company to insist or not to insist for the export order. "Since WHO GMP requirement arises only when the importing country demands it, the export order or query is always a helping tool to assess the actual need for the same," says Dr Venkateswarlu, deputy drug controller, India (West).
But in any case, asking for WHO GMP certification for government/institutional purchases is not at all desirable as it effectively de-recognizes the country's GMP certification as per the Schedule M of the Drugs & Cosmetics Act, he adds.
Ironically, the industry especially the small-scale sector is now increasingly raising the grievances of not being able to compete in the domestic institutional and government tenders as they are demanding the WHO GMP certification as the basic criteria to accept the document.
The CDSCO officials added that it is unfortunate that the institutions and even the government departments are asking for WHO GMP as primary condition for suppliers to participate in the tenders despite the department having communicated it to them several times.