ASSOCIATION OF DRUGS AND PHARMACEUTICALS MANUFACTURERS A P Vs. A P HEALTH MEDICAL HOUSING AND INFRASTRUCTURE DEVELOPMENT CORPORATION HYD

JUDGEMENT

(1.) The petitioner, an association of manufacturers of medicines, drugs and Pharmaceuticals, has filed this writ petition praying for a Writ of Mandamus declaring the action of the first respondent in prescribing the holding of WHO GMP (World Health Organization Good Manufacturing Practices) Certificate for the manufacturers to participate in the tenders as per Tender Notification, dated 10-10-2001 for supply of I.V. fluids and general drugs under Rate Contract 2001-03, as being arbitrary and irrational, and for a consequential direction to the first respondent to consider the case of the members of the petitioner-Association and other licensees who manufacture medicines /drugs/pharmaceuticals.

(2.) While admitting the writ petition on 19-10-2001, this Court passed an interim order in W.P.M.P.No. 27836 of 2001 directing the first respondent to consider the tenders of the members of the petitioner- association without insisting that they should possess WHO GMP Certificate, pending disposal of the writ petition. After receiving the notice, the first respondent has filed an application being W.V.M.P.No. 20 of 2002 on 28-12-2001 praying this Court to vacate the interim order dated 19-10-2001. At the request of the learned Counsel appearing on behalf of the petitioner and the learned A4ditional Advocate General appearing on behalf of the first respondent, the main writ petition was heard, and is being disposed of finally by this order. FACTUAL BACKGROUND,

(3.) All the members of the petitioner-association hold licences under the Drugs and Cosmetics Act, 1940 (for short 'the Drugs Act') and the Rules made thereunder known as "Drugs and Cosmetics Rules, 1945" (for short 'the Drugs Rules'). All of them allegedly adhere to good manufacturing practices (GMP), as enumerated in Schedule M to the Drugs Rules. They were given GMP Certificates by the Director, Drug Control Administration of Andhra Pradesh. All the members of the petitioner-association were supplying drugs, medicines and pharmaceuticals to the State Government and State Government Corporations without the status of WHO GMP, and during the last 25 years there was no such qualification prescribed. The World Health Organization, Geneva in Switzerland, recommended certain good manufacturing practices known as 'WHO GMP', which are altogether different. Any requirement of WHO GMP, as pre-qualification as eligibility for participation in the tenders would totally eliminate the small scale industries with GMP. As a consequence, the cost of procuring drugs would go up resulting in loss of public money. The tender condition subverts public interest. The petitioner also contends that when the Drugs Act and the Rules do not define and do not contemplate any grading as WHO GMP and only requires the licensees to comply with good manufacturing practices under Schedule M to the Rules, the prescription incorporated in the impugned tender notification is arbitrary and irrational. The classification of the drug manufacturers into those with WHO GMP as one category and those with GMP as another category is irrational and does not have any reasonable nexus with the object sought to be achieved, which is to place orders with the enlisted licensed manufacturers for supply I.V. Fluids and general drugs to Government at a reasonable rate contract. It is further stated that when the Drugs Act and the Rules do not prescribe or contemplate any certificate to conform to WHO GMP, the State cannot insist on such certification. The items which are no (sic. the) subject-matter of the tender are not of that high degree of scientific precision and the I.V. Fluids and general medicines which are sought to be procured are routine drugs and medicines regularly purchased every year by the first respondent.