The Department of Pharmaceuticals (DoP) has invoked the powers of Section 3 (i) of DPCO, 2013 for ensuring compliance of the price capping of the coronary stents along with maintaining its uninterrupted supply in the country.
The DoP's action in this regard comes in the wake of some reports regarding shortage of coronary stents in the market/hospitals which has now come to the notice of the Department. After due deliberations on the current situation and alternatives available with the government to resume normal supply of the coronary stents in the country, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013.
As per Section 3 (i) of DPCO, 2013, the government may, with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of noncommercial use in public interest, direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase the production and to sell such active pharmaceutical ingredient or bulk drug to such other manufacturer(s) of formulations and to direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be.
Now, the DoP has directed the companies manufacturing coronary stents in India to maintain production/import/supply of the coronary stents; and to submit a weekly report on coronary stents produced and distributed. They will also submit a weekly production plan for the next week to NPPA and DCGI.
NPPA and DCGI are also empowered to extend these directions to any other producers of coronary stents in India during this three months period. This order will be valid for three months (except for Absorb Classic BVS and Absorb GT I BVS stents of Abbott Healthcare) and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period.
The NPPA has sent notices to a large number of medical devices companies. They include India Medtronic Pvt. Ltd, Mumbai; Stryker India Pvt. Ltd, Gurgaon; Johnson & Johnson Private Limited, Mumbai; Zimmer India Pvt. Ltd, Gurgaon; MIV Therapeutics (India) Pvt. Ltd, Surat; Biorad medisys Pvt Ltd, Bengaluru; Abbott India Limited, Mumbai; B. Braun Medical (India) Pvt. Ltd, Mumbai; Smith & Nephew Healthcare Pvt. Ltd, Mumbai; Advanced Bionics India Pvt. Ltd, Bangalore; Meril Life Sciences, Vapi Gujarat; St. Jude Medical India Ltd, New Delhi; Sorin Group India Pvt Ltd, New Delhi; Shree Pacetronix Ltd, Pithampur, M.P; Medived Innovations Pvt. Ltd, Bengaluru; Sahajanand Medical Technologies Pvt. Ltd, Surat; TTK Health Care, Chennai; Sharma Pharmaceuticals, Vadodara; Appasamy Associates, Chennai; Sky Surgicals, Rajkot; Pitkar Orthotools, Pune; and Inor Medical Products, Mumbai.
The list also includes Vasmed Technologies, Cochin; Biosensors Interventional Technologies (India) Pvt. Ltd, Valsad, Gujarat; BL Lifesciences Private Limited, New Delhi; Clairvoyance Consulting, New Delhi; Ernergo (India) Consulting Pvt. Ltd, Hyderabad; Globe Bio-Medicals, Mumbai; Hexacath India, Pune; Intas Medi Devices Limited, Ahmedabad; Kirloskar Technologies Private Limited, New Delhi; Lepu Medical Technology (Beijing) Co. Ltd, Gurgaon; Minvasys India Private Limited, Surat; OptoEurocor Healthcare Ltd, Bengaluru; OrbusNeich Medical (India) Pvt. Ltd, Delhi; Uniapex Biomedics, Mumbai; Abbott Healthcare Private Limited, Mumbai; Turmo India Private Limited, Gurgaon; Boston Scientific, Gurgaon; Biotronik Medical Devices Private Limited, New Delhi; India Medtronik Private Limited, Mumbai; Translumina Therapeutics LLP, Uttarakhand; Meril Life Sciences Private Limited, Gujarat and Mumbai; Nano Therapeutics Private Limited, Surat; Envision Scientific Private Limited, Surat; MTV Therapeutics (India) Pvt. Ltd., Surat; Sahajanand Medical Technologies Private Limited, Sahajanand Estate, Surat; Sahajanand Laser Technologies Private Limited, Gandhinagar; Invent Bio-Med Private Limited, Surat; Vascular Concepts Limited, Bengaluru; Relisys Medical Devices Limited, Andhra Pradesh; Envision Scientific Pvt Ltd, Plot No. 108, Surat; Multi Medics, Baddi; N.S. Remedies Pvt Ltd, Kolkata; Terumo Corporation, Chennai; S3V Vascular Technologies Pvt. Ltd, Hyderabad; S3V Vascular Technology Pvt. Ltd, Mysore; Vascular Solutions India Private Limited, Mumbai; Phoenix Cardio Care India Pvt. Ltd, Kolkata; Choksi Imaging Ltd, Pondicherry; Envision Scientific Pvt. Ltd., Surat; and Manju Enterprises Pvt. Ltd, New Delhi.