Usha Sharma – Mumbai
July 29 was the D-day when the first batch of medicines with revised prices as per the Drug Price Control Order 2013 (DPCO) were to be on chemist shelves. But as industry associations and individual companies file cases and make representations to stall/postpone implementation of the new pricing regime, state and union territory regulators reportedly have not yet received any official communication from the National Pharmaceutical Pricing Authority (NPPA) empowering them to monitor the price revision process.
The Department of Pharmaceuticals (DoP), in order to make affordable medicines available in India, had released an order on May 15 and provided a 45-day period to pharma companies to implement the revised prices on medicines falling under the Drug Price Control Order 2013 (DPCO). In the first batch on June 10, National Pharmaceutical Pricing Authority (NPPA) has revised 86 formulation packs but more than a month later there is no official communication to Indian State/Union Territories’ offices authorising them to monitor the implementation of the price revision process.
As per a DoP order dated May 15, any gazetted officer of the Central Government or of a State Government, in order to check compliance with this order could enter and search any place as well as seize any drug, along with the containers, packages or coverings.
However as per another DoP order dated May 30, the Central Government has directed that only the NPPA would exercise the functions of the Central Government on this issue and in turn empower the state regulators to take action if required.
Commenting on the two orders, Dr Bharatesh Jagashetty, Drug Controller, Karnataka said, “So far we have not received any official direction either from the Government of India or NPPA. However, we have approached the Karnataka Government and asked them to give our drug controller officers the power to authorise such actions in order to monitor the implementation process as per paragraph 30. We hope to receive a formal notification from the state government in a couple of days.”
When contacted by Express Pharma, and asked to clarify who was the designated authority to implement the process, Pradeep Yadav, Joint Secretary, DoP replied, “DoP has mentioned that NPPA is the authorised body to govern the order through the State and Union Territories (UTs). If NPPA has not communicated officially with the state/UTs drug regulators, then we will direct them and very soon all the states and UTs will get a notification from NPPA.”
Omprakash Sadhwani, Joint Commissioner, Food and Drugs Administration commented, “Though we have not heard anything officially from NPPA, we have still started working on the revised prices at Maharashtra FDA office. In a day or two, our drug inspectors will make surprise visits to different chemist shops located in Maharashtra and check whether pharma companies have implemented the revised prices or not. However, we are also awaiting an official communication from NPPA.”
Dr Hemant Koshia, Commissioner, Food and Drugs Control Administration (FDCA), Gujarat highlights, “As per DPCO 2013, we have already started collecting primary data related to price variation of the revised drug prices and our drug inspectors are working on it.”
He also mentioned, “It is a known fact that the Government of India enforces the orders and state authorities are liable to implement in their respective states. However, we hope that some official communication will be released by the NPPA and we will be officially authorised to work on this direction. We hope to hear from NPPA in the next two to three days.”
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