The proprietor is a Director (retd.) from the
Government of India, Department of Pharmaceuticals. He was associated with
framing of DPCO, 2013 and its subsequent implementation.
He has a vast
experience and knowledge of Drug (Prices Control) Orders Government procedures,
NPPA issues, extant rules and regulations pertaining to the
subject.
He is also in a
position to defend the interests of companies and protect them by linking
specific provisions of law, rules and regulations with the grievances of the
companies.
Our Offerings
- Hassle -free services for pharmaceutical manufacturing/ marketing companies in compliance of DPCO Matters.
- Enabling companies to keep pace with, understanding and being compliant with latest Government orders.
Our Services
Review Petitions
- Examining facts of the case with reference to Drug policy, NLEM and Drug (Prices Control) Order, 2013(DPCO, 2013) to decide suitability of the case for a review under Para 31 of DPCO.
- Suggesting the grounds on which NPPA’s Price notification can be challenged keeping in view the extant rules regulations and the Review Orders already issued by the Government.
- Preparing Review Applications under Para 31 of DPCO, 2013.
- Appearing for a Review hearing on behalf of the petitioner company.
- Suggesting steps to be taken by the petitioner company after issue of the review order by the reviewing authority.
Price Control Matters- Suggesting revision of prices and their calculation on Annual revision and Revision of prices based on WPI.
- Preparing summary of orders issued by NPPA/ Government and their likely impact on the company.
- Preparing representations on behalf of the company on the draft working sheet uploaded by NPPA on its website.
- Advising companies on whether their formulations fall under the category of Scheduled formulations, non-scheduled formulations or new drugs.
- Advising the companies on annual increase of prices of their formulations permitted under the extant rules and regulations.
Overcharging issues
- Advising companies on the effective date of price notifications.
- Steps to be taken by the company to avoid overcharging notice.
- Preparing replies to overcharging notices on behalf of companies.
Other Issues
- Filing of IPDMS Reports on behalf of the company.
- Advising on filing price information in form V by the company.
- Sending monthly summary of important activities during the period to the companies.
Our Services Fee
We provide the services on monthly retainer-ship
basis as well as on case to case basis on a fixed fee.
Related Services
We also help in engaging experienced legal counsel on
separate payment terms.
Past Projects and Experience
Apart from being a hearing authority in the Government, I also attended to review hearing cases of:-
- M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
- M/s Paviour Pharmaceuticals Pvt. Ltd., New Delhi
- M/s Green Signal Bio Pharma Limited, Chennai.