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2020 Supreme(Mad) 1776

IN THE HIGH COURT OF JUDICATURE AT MADRAS
N. KIRUBAKARAN, J.
Vinkem Labs Ltd., Represented by its Managing Director M. Perumal & Others - Appellants
Versus
Union of India, Represented by its Secretary to Government, New Delhi & Others - Respondents
W.P. Nos. 11777 & 16622 of 2017 & W.M.P. Nos. 12750, 12751 of 2017 & 6775 of 2018
Decided on : 30-09-2020

Advocate Appeared:
For the Appellant :Om Prakash, Senior Counsel, K. Sumathi, Advocate.
For the Respondents:G. Karthikeyan, Srinivasamurthy, T. Ravichandrdan, T.M. Pappiah, C. Mohan, Vijayan, Advocates, N.L. Rajah, Amicus Curiae.

JUDGMENT :

(Prayer: Petition is filed under Article 226 of the Constitution of India for issuance a Writ of Mandamus directing the respondents to consider and grant the representation of the petitioner dated 28.04.2017 to give preferential allotment/necessary quota in all public procurements for medicines manufactured with indigenously produced Active Pharmaceutical Ingredients and facilitate and implement the same with enabling criteria and applying concessional measures recommended by the expert committee constituted for revival of the Indian Bulk Drugs industry within a reasonable time frame to be fixed by this Court.

Petition filed under Article 226 of the Constitution of India for issuance of Writ of Certiorarified Mandamus calling for the records of the respondents, quash the communications dated 08.03.2017 in Reg.No.Vinkem 2016-17 issued by the 2nd & 3rd respondents, that is, Deputy General Manager of NABARD and Assistant General Manager of Bank of India, dated 03.05.2017 in Reg.No.CZ/ARB/MKS/09 issued by the 3rd respondent, that is, Assistant General Manager of Bank of India and dated 21.06.2017 in Reg.No.NB.T.N.DOR.1CD/Cofinance/140/vinkem labs-2017-18 issued by the 2nd Respondent, that is, Deputy General Manager of NABARD and direct the Respondents to reckon the stocks of the Petitioner valued at Rs.41.25 crores by experts nominated by Banks and the sum of Rs.1.46 crores realized by Sale of Promoter's Personal Asset towards Margin Contribution for the Corporate Debt Restructuring and to extend to the Petitioner Sanction in terms of the Respondents' letter dated 23.01.2017 with further concessions in interest as per the recommendations of the Expert Committees and direct the Respondents to make the sanction and commence disbursements within a period of four weeks to enable the Petitioner to participate in the subsisting Public Procurement Tenders for the current year.)

“TAMIL”

A country is one that strenuously guards against spiralling hunger, endemic disease and ravage of the foe.

Thirukkural - Couplet 734

2. If so, what would become of a nation that leaves supply of its essential lifesaving medicines, livelihood of a tranche of its farmers to the mercy of its competing neighbour is the question that arises for consideration in these Writ Petitions.

II. India’s near total dependence on imports from one single nation which is an enemy country for essential life-saving medicines

3. India has emerged as a pioneer in pharmaceuticals. Yet, for the basic ingredients of medicine making, it is heavily dependent on imports from one single neighbour nation, viz., China. This dependency handicaps us in responding effectively to security and other breaches by the neighbour. It also makes our patients to more often contend with spurious and sub-standard drugs and placing them in a vulnerable prospect of going without medicines if tensions escalate between the two countries, especially after galwan valley tussle.

4. Though we do not import medicines as such, we import the active ingredients of a medicine that is known as Active Pharmaceutical Ingredients/Bulk Drugs and make finished dosages out of it for domestic and export purposes.

5. To appreciate this better, it would be useful to know what is ‘R&D in Generics’, ‘Active Pharmaceutical Ingredients [‘API’]’ & ‘Formulations’.

6. R&D in Generics refers to ‘Reverse’ Engineering of equivalents of Proprietary Medicines by independent process. Generic Medicines could enter market upon expiry of patent period for a Proprietary Medicine.

7. ‘Active Pharmaceutical Ingredients’ (‘APIs’) refers to the ingredients in a medicine that act upon the illness of the patient. These ingredients constitute the nucleus of any medicine and are also referred to as ‘Bulk Drugs’.

8. ‘Formulations’ refer to finished dosages made adding excipients to Active Pharmaceutical Ingredients that are administered to patients. Excipient is an inactive substance that serves as the vehicle or medium for a drug. Excipients are thi

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