IN THE HIGH COURT OF GAUHATI
Suman Shyam, J.
Ridley Life Science Pvt. Ltd. – Appellant
Versus
State of Assam and Another – Respondents
Writ Petition (Civil) No. 4883 of 2019
Decided On : 14-11-2019
Drugs and Cosmetics Act, 1940 – Constitution of India – Articles 14, 19(1)(g), Article 226 – Drugs and Cosmetics Rules, 1945 – Part VII, Rules 71,74,76, 78, 68, 85 – Illegal – Arbitrary – Malafide exercise – Discriminatory – Legality – Writ petitioner herein is a private limited company having its corporate office at Narela – Aggrieved by insertion of Clauses 2.3.1 and 2.5.1 in NIT issued by respondent No. 2 inviting Online tenders for supply of essential drugs to health facilities under department of Health and Family Welfare, Government of Assam, for a period of two years, present writ petition has been filed – Held, documents available on record pertaining to recent years also unequivocally go to show that a number of State Governments including States of Maharashtra, Kerala, Karnataka, Gujarat and some Central Government agencies have inserted identical eligibility clauses in similar tenders issued for supply of medicines – From above, it is apparent that decision to insert impugned conditions in present NIT is not an isolated event but is in consonance with practice followed across nation – Writ Petition is Dismissed
JUDGMENT :
Suman Shyam, J.
1. Heard Mr. Sumit Rajput, learned counsel appearing on behalf of the writ petitioner. I have also heard Mr. D. Saikia, learned senior counsel assisted by Mr. B. Gogoi, learned Standing Counsel, Health Department, Assam, appearing for the respondents.
2. The writ petitioner herein is a private limited company having its corporate office at Narela, New Delhi. Aggrieved by insertion of Clauses 2.3.1 and 2.5.1 in the NIT dated 05.07.2019 issued by the respondent No. 2 inviting Online tenders for supply of essential drugs to health facilities under the department of Health and Family Welfare, Government of Assam, for a period of two years, the present writ petition has been filed.
3. The case of the writ petitioner, in a nutshell, is that, it is a manufacturer of pharmaceutical drugs and is holding Drug Manufacturing Licence No. 1930/1931 issued under the Drugs and Cosmetics Act, 1940. The petitioner is also holding a valid "GMP" and "GLP" certificate as well as no "conviction certificate" issued by the competent authority and therefore, is competent to manufacture and market pharmaceutical products. The writ petitioner was interested to participate in the tender process initiated by the NIT dated 05.07.2019. However, due to the insertion of clauses Clause 2.3.1 and 2.5.1 in NIT the petitioner has been rendered in-eligible to participate in the tender. Hence, this writ petition for quashing the aforementioned eligibility clauses contained in the tender.
4. Clause 2.3.1 provides that the bidder must have three years market standing of the items quoted in the bid. As per Clause 2.5.1 a valid WHO-GMP certificate issued by the appropriate licensing authority not older than one year from the date of submission of the bid is an essential condition for the bidders to participate in the bidding process. The writ petitioner herein, admittedly, does not hold a WHO-GMP Certificate and therefore, did not meet the eligibility condition prescribed under the NIT. The petitioner's case is that clauses 2.3.1 and 2.5.1 have been deliberately inserted in the NIT so as to extend undue favour to a chosen few.
5. By placing heavy reliance on an un-reported judgment of the Jammu and Kashmir High Court in the case of Rohit Drugs and Others vs. State and Others, decided on 04.03.2002 and another decision of the High Court of Judicature at Uttaranchal in the case of Poddar Pharmaceutical Ltd. and Others vs. State of Uttaranchal and Others decided on 24.05.2003 Mr. Rajput has argued that in both the aforementioned decisions it has been categorically held that "WHO-GMP" certificate is required only by the firms who intend to export the medicines and therefore, there is no requirement for a manufacturer to hold such a certificate for the purpose of domestic supplies. By producing a copy of the order passed by the Hon'ble Supreme Court dismissing the SLP preferred against the aforesaid decision of the Uttaranchal High Court, Mr. Rajput has argued that the decision of the Uttaranchal High Court having been affirmed by the Supreme Court, law is now settled that a "WHO-GMP" certificate is not required for a domestic supplier.
6. By referring to a circular issued by the Drug Controller General of India dated 01.03.2009 whereby, all the State Drug Controllers have been asked not to entertain request for issuing of WHO-GMP certificate by the manufacturers of pharmaceuticals products to supply in India, Mr. Rajput has emphatically argued that a domestic drug supplier would not be entitled to even apply for a "WHO-GMP" Certificate and if there is any doubt on the aforesaid issue, the same stood resolved in favour of his client due to the contents of the circular dated 01.03.2009.
7. By relying upon another unreported decision of the High Court of Judicature at Hyderabad in the case of Bharat Biotech International Limited and Others vs. A.P. Health and Medical Housing and Infrastructure Development Corporation and Others decided on 10.12.2002, Mr. Ra
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