Monthly Archives: September 2014

NPPA Issues Order For All Pharmaceutical Manufacturers And Firms To Register Under The Integrated Pharmaceutical Database Management System (IPDSM) Of India

NPPA Issues Order For All Pharmaceutical Manufacturers And Firms To Register Under The Integrated Pharmaceutical Database Management System (IPDSM) Of IndiaThe National Pharmaceutical Pricing Authority (NPPA) of India has been assigned the task of implementing the National Pharmaceutical Pricing Policy (NPPP), 2012 and the Drugs (Prices Control) Order 2013 (DPCO 2013). As an authority to manage and regulate these issues, NPPA is required to take all necessary measures for smooth and efficient implementation of the NPPP, 2012 and the DPCO, 2013.

Information technology has also introduced both challenges and opportunities for pharmaceutical stakeholders of India. Indian government has recently announced formulation of Electronic Health Record (EHR) Standards of India. AIIMS Bhubaneswar has also announced that it will launch Electronic Health Card for its patients. AIIMS, Delhi has introduced a system where patients can fix appointments with doctors over phone.

However, regulatory issues in these regard have been ignored by various healthcare stakeholders in India. For instance, online sale and purchase of prescribed drugs and medicines in India is happening in an unregulated manner. There are specific laws and regulatory requirements for opening of online pharmacies in India. But almost all of the online pharmacies are not following various laws of India applicable in this regard.

Although a full fledged action against illegal online pharmacies of India is still awaited yet the NPPA has issued a Notice to all pharmaceutical manufacturers to register themselves under the Integrated Pharmaceutical Database Management System (IPDSM) for online filing of returns in Form II, III, and V under DPCO, 2013. The term “manufacturers” for the purpose of this Notice/Order means any person who manufactures, imports and markets drugs for distribution or sale in the country.

Besides online filing of returns, the IPDSM would also ensure monitoring, fixing and revision of drug prices in India. The registration process is compulsory in nature and it will be open upto 31st October 2014 after which that data inputting facility shall be made available to all registered users for submission of online reports in respect of form II, III and V under DPCO 2013.

According to NPPA availability of reliable database is a necessary pre-requisite for carrying out the functions of price fixation and price revision in respect scheduled drugs; price fixation in respect of new drugs; monitoring the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulations; and monitoring the prices of non-scheduled formulations.

This reporting obligation on the part of pharmaceutical manufacturers is a legal obligation, which they are required to carry out with full and correct disclosure of information in a timely manner at prescribed intervals. Any default in the reporting would be deemed to be an act of contravention of the DPCO 2013 and therefore attracts penalties under the Essential Commodities Act, 1955.