Question : MULTIPLE DRUGS UNDER SAME NAME

(a) whether the Drug Controller General (India) has asked all the State drug regulators and pharmaceutical firms to withdraw several medicines sold under the same brand name but used to treat different ailments in the country;

(b) if so, the details of such medicines alongwith the names of their manufacturers;

(c) the number of such medicines withdrawn from the market till date;

(d) whether the DCG(I) proposes to set up any centralised drug brands database in order to effectively enforce the same and track such medicines across the country; and

(e) if so, the details thereof and if not, the reasons therefor?

THE MINISTER OF HEALTH & FAMILY WELFARE (SHRI GHULAM NABI AZAD)

(a) & (b): Yes. “AZ” brand was being used for Albendazole, Azithromycin and Cetirizine formulations as under:

(i) Cetirizine, manufactured by M/s Sienna Formulations Pvt. Limited, Vadodara, Gujarat.

(ii) Albendazone, manufactured by M/s Cure Quick Pharma, Karnal, Haryana.

(iii) Azithromycin, manufactured by M/s Eugenics, Lucknow, Uttar Pradesh.

The office of Drugs Controller General (India) [DCG (I)] had requested the State Drugs Controllers and the concerned manufacturers on 7.2.2011 to withdraw the permission for AZ brand and other similar cases of same brand names under their jurisdiction.

(c): The formulations for which permissions have since been withdrawn as per information provided by State Licensing Authorities:

(i) Zocor Dry Syrup, Zocor Drops & Zocor-125 manufactured by M/s Per Pharmaceuticals, 272, Indl. Area, Phase-II, Panchkula.

(ii) Neogest-50 and Neogest-100 manufactured by M/s Oscar Remedies Pvt. Ltd., Oscar House, Baddi, Majara, Yamuna Nagar.

(iii) Metagesic Suspension & Metagesic Plus Syrup mfd. by M/s Amree Pharmaceuticals, 1/10, Shiv Colony, Kaithal Road, Karnal.

(iv) AZ suspension (Albendazole Suspension) mfd. by M/s Cure Quick Pharmaceuticals, 20/3, HSIDC, Karnal.

(v) AZ tablets manufactured by M/s R.H. Laboratories, Gondpur Indl. Area, Paonta Sahib, Distt. Sirmour, HP. (Marketed by M/s Cure Quick Pharma, Karnal, Haryana)

(vi) AZ suspension manufactured by M/s R.H. Laboratories, Gondpur Indl. Area, Paonta Sahib, Distt. Sirmour, HP. (Marketed by M/s Cure Quick Pharma, Karnal, Haryana)

(vii) Calcimax manufactured by M/s Alps Pharmaceuticals Pvt. Ltd. Almora, brand of M/s Meyer Organics Pvt. Ltd.

(viii) Col-Q manufactured by M/s G.S. Pharmaceuticals Pvt. Ltd. Roorkee brand of M/s Blue Cross Laboratories

(ix) AZ Tablet - Cetirizine, manufactured by M/s Sienna Formulations Pvt. Limited, Vadodara, Gujarat.

(d) & (e): There is no proposal under consideration at present to set up a centralized drug brand data base as the Drugs & Cosmetics Act, 1940 essentially regulates the quality of the drugs marketed in the country and does not provide for recognition of brand names under it.