The Department of Pharmaceuticals (DoP) has directed the companies manufacturing coronary stents in India to submit a weekly report on coronary stents produced and distributed to maintain a record of production, import and supply of the coronary stents in the country.
In separate letters to 62 manufacturers, the DoP has stressed the need for ensuring compliance of the price capping of the coronary stents along with maintaining its uninterrupted supply.
“Some reports regarding shortage of coronary stents in the market/hospitals have 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, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013”, the DoP said in its letter to Abbott Healthcare Private Limited.
Quoting Section 3 (i) of DPCO, 2013, the letter says, “The Government may,-(i) 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 non- commercial 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.”
“The companies manufacturing coronary stents in India are directed 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”, the letter to Abbott said.
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 next six months and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period, it further said. Abbott Healthcare Private Limited, Turmo India Private Limited, Boston Scientific, Biotronik Medical Devices Private Limited, India Medtronik Private Limited, Translumina Therapeutics LLP, Meril Life Sciences Private Limited, Nano Therapeutics Private Limited, Envision Scientific Private Limited, MIV Therapeutics (India) Pvt. Ltd, Sahajanand Medical Technologies Private Limited, Sahajanand Laser Technologies Private Limited, Invent Bio-Med Private Limited, Vascular Concepts Limited, Relisys Medical Devices Limited, Envision Scientific Pvt Ltd, Multi Medics, N.S. Remedies Pvt Ltd, Terumo Corporation, S3V Vascular Technologies Pvt. Ltd Hyderabad, S3V Vascular Technology Pvt. Ltd Mysore, Vascular Solutions India Private Limited, Phoenix Cardio Care India Pvt. Ltd, Choksi Imaging Ltd., Envision Scientific Pvt. Ltd Gujarat, Manju Enterprises Pvt. Ltd, Vasmed Technologies, Biosensors Interventional Technologies India Pvt. Ltd, BL Lifesciences Private Limited, Clairvoyance Consulting, Emergo (India) Consulting Pvt. Ltd, Globe Bio-Medicals, Hexacath India, IntasMedi Devices Limited, Kirloskar Technologies Private Limited, Lepu MedicalTechnology (Beijing) Co. Ltd, Minvasys India Private Limited, OptoEurocor Healthcare Ltd, OrbusNeich Medical (India) Pvt. Ltd, Uniapex Biomedics, India Medtronic Pvt Ltd, Stryker India Pvt. Ltd, Johnson & Johnson Private Limited, Zimmer India Pvt. Ltd, MIV Therapeutics (India) Pvt. Ltd Gujarat, Bioradmedisys Pvt Ltd, Abbott India Limited, B. Braun Medical (India) Pvt. Ltd, Smith & Nephew Healthcare Pvt. Ltd, Advanced Bionics India Pvt. Ltd, Meril Life Sciences, St. Jude Medical India Ltd, Sorin Group India Pvt Ltd, Shree Pacetronix Ltd, Medived Innovations Pvt. Ltd, Sahajanand Medical Technologies Pvt. Ltd, TTK Health Care, Sharma Pharmaceuticals, Appasamy Associates, Sky Surgicals, PitkarOrthotools and Inor Medical Products are the companies to whom the DoP has sent letters.