ROHIT DRUGS Vs. STATE

JUDGEMENT

(1.) Admitted.

(2.) Petitioners in this petition are the licencees which licences have been issued to them under the Drugs and Cosmetics Act of 1940 and Drugs and Cosmetics Rules of 1945. They want to participate in the process of tender issued by the respondent State. They are not being permitted to do so. There is a condition in the tender notice that a person wanting to take part in this process must possess a Good Manufacturing Practice (WHO-GMP) certificate. Petitioners do not possess this certificate and as indicated above, they are not being allowed to participate in the tender process. According to the petitioners it is not necessary to have this certificate. It is this condition (condition No. 2), which is the subject-matter of challenge in this petition. It would be apt to notice this condition. This is being reproduced below :- Firms should be registered with the Director General of Quality Assurance (DGQA) Ministry of Defence. Government of India for manufacture and supply of Drugs/Medicines/items articles which comes under Drugs and Cosmetics Act quoted for Defence Services should be having "Good Manufacturing Practice (WHO GMP) Certificate issued by the Drug Controller of India or State Drug Controller in accordance with the WHO recommendations strictly called as (WHO GMP), are authorised to tender directly or through their authorised Distributors in that case letter of authority on the form enclosed as Annexure A shall have to be furnished by the Principal.

(3.) At this stage, it would be pertinent to notice that in para 1 of the terms and conditions, it has been mentioned that the original suppliers/manufacturers should have a valid Drug Licence in respect of items which come under Drugs and Cosmetics Act, 1940 from the Drug Controller of India or State Drug Controller.........."