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.
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