The Indore based Bright Drugs Industries Ltd., has demanded the Kerala Drug Controller to review his decision to ban a few batches of aluminium hydroxide and magnesium tricylicate tablets manufactured by the company in the Kerala market, and to refrain from publicizing details of the test reports among the public.

In an official letter addressed to the DC with copies to Pharmabiz, DCGI and Deputy Drugs Controller (CDSCO), South Zone, the firm contended that details of the ban published in Chronicle Pharmabiz issue dated 06/05/04 has caused irreparable damages like loss of business and reputation to the company. The DCGI in one of the meetings had recommended to all State Drug Controllers to refrain from publicizing details on drugs of substandard quality, since it could create confusion in the minds of procurement agencies and public. Further, there was no provision in the Drugs and Cosmetics Act or rules for issuance of such press releases.

As a damage control exercise, the DC should review the test report and issue a fresh press release informing the public on deletion of the products of the company from the list of substandard drugs, demanded J R Agarwal, managing director of Bright Drugs Industries Ltd.

Reacting to this, T P Gopinathan, Drug Controller, Kerala told pharmabiz that if the company has doubts on the quality mechanism of the state drug control laboratory, it has every right to appeal for reviewing the samples by tests conducted at the Central Drugs Laboratory, Kolkotta, as per the provisions available in the rules.

Nevertheless, the issue of informing the public about the quality of drugs floating in the market was entirely under the discretion of state drug controllers. Kerala was yet to know or receive any recommendation from the DCGI to refrain from publicizing information on substandard or spurious drugs. Apart from publicizing the details, Kerala gives information on substandard drugs to other state drug controllers and the Deputy Drugs Controller, South Zone. Kerala would continue to do so in the interest of the general public, said Gopinathan.

Bright Drugs Industries said the entire quantity of the drugs/batches of aluminium hydroxide and magnesium tricylicate tablets was supplied to two government institutions in Tirur and Kozhikkode as per the Central Purchase Committee (CPC) contract of the Government. The sample test reports of the Government analyst and the Drugs Inspector, Kozhikkode were objectionable on technical and legal grounds, and therefore the matter may be referred back to the Government analyst for review of test or may be retested at the Central Drugs Laboratory, Kolkotta, demanded the company.