India’s drug price watch dog National Pharmaceutical Pricing Authority (NPPA) has issued a notice to all pharmaceutical associations warning that it will be constrained to take ‘appropriate action’ against their member companies who have yet to register in the Integrated Pharmaceutical Database Management System (IPDMS).
Since NPPA will be launching this system shortly, it has urged the associations to ‘impress upon their member companies to register themselves with the IPDMS immediately.’
According to the notice dated May 1, of the top 100 pharma companies, 59 companies have not yet registered with the system. NPPA has alerted to take appropriate actions against non-registered pharma companies under the provisions of DPCO 2013 read along with the Essential Commodities Act, 1955.
NPPA in collaboration with the National Informatics Centre, had developed the Ingredient Pharmaceutical Data Base Management System (IPDBMS), which aims at facilitating online submission of mandatory returns/ reports under the DPCO, 2013 by manufacturers, including companies which make, import and market drugs for distribution or sale in the country.
NPPA has requested all manufacturers to register themselves and complete registration formalities, which include company details, head office/ corporate office address, contact person details, product source details and product details.
According to the NPPA website, about 300 pharma companies have already registered with the IPDMS, covering more than 20, 000 formulation packs. The list of 59 pharma companies which have not registered includes Dr Reddy’s Laboratories, Cadila Pharma, Mankind Pharma, MSD Pharmaceutical, Ranbaxy Laboratories, Cipla, USV, Wockhardt among others.
Commenting on the recent notice issued by the NPPA, Daara Patel, Secretary General, Indian Drug Manufactures Association (IDMA) said, “After the recent notice issued by the NPPA, today, we will be writing a letter to all our members asking them to comply with the NPPA order and register their companies accordingly. ”
S V Veerramani, President, IDMA expressed, “IDMA appreciates the overall move of NPPA to bring in uniformity and compliance of the data to be provided by the industry. But, there have been some concerns like absence of provision to make any modification or addition in the submitted data, submission of production capacity and duplication of data for the same products from the manufacturer as well as marketer (if they are different).”
Patel elaborated, “There is also a concern regarding Loan License business, whether the contract manufacturer or the brand owner has to submit the data for the particular product. Also if part of the data has been missed out there is no provision to include or make changes and the company has to resubmit the entire data, which should be relooked seriously by NPPA.”
While raising concerns of the SSI players, Veerramani mentioned, “We also submitted that the SSI manufacturers without adequate technical manpower may find it difficult to provide the data online. We have also attended the meetings convened by NPPA regarding IPDMS.”
Patel also informed that the IDMA had made two representations to the NPPA last year (on October 10 and December 30) concerning this issue. During the meetings, there were discussions on issues related to uploading of product details through Excel sheets and implementations of e-filing of data etc by pharma companies on IPDMS.
Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI) said, “We have also received the communication from the NPPA and have forwarded it to all our members. We are hoping that they will handle it on their own, as we won’t be able to track individual companies’ adherence to it.”
As per the IPDMS, pharma manufacturers have register online which has been initiated by the NPPA. The initial target date for implementation of the system was by October last year.
Veerramani informed, “While NPPA have made the production capacity details optional, and also assured to make suitable modifications subsequently for changes if any, the operational problems need to be fully sorted out.”
Despite the extension of the time limit by the NPPA, many pharma companies have not registered themselves with the IPDMS system. NPPA has already provided the user ID and password to the registered companies to make online submission of data as required under the provisions of DPCO, 2013.