Act on kamble panel report

July, 2016

Drug control authorities in the country have been facing the challenge of regulating the internet sales of pharmaceutical products from 2014 with the emergence of these new class of traders. Initially there were only very few players in the scene and their sales were restricted mainly to customers outside India. Some cases of such sales in violation of the Drugs & Cosmetics Act were detected by Maharashtra FDA during 2014 and 2015. Then after repeated complaints from the retail chemists and wholesalers against the internet sales of medicines, the Drugs Controller General of India appointed a committee under Harshdeep Kamble, commissioner of Maharashtra FDA, to explore the possibility of allowing online trading in pharmaceuticals and laying down specific rules. Although the committee submitted its recommendations in this regard last year, no decision has been taken by the DCGI. In the meanwhile more online traders have entered into the field affecting the sales of traditional players. Now, the online traders are well organized and have formed Internet Pharmacy Association with a dozen leading players offering discounts and catering mainly to the domestic market.

Internet sales of medicines do help customers to get medicines without visiting the pharmacy outlets and the offer of even 10 to 15 per cent discount on most of the medicines by the e-traders is quite tempting. In fact, that has led to a steady increase in sales of several medicines online by some of well-known e-commerce companies. It is true that old and seriously sick patients can have a convenient access when medicines are delivered at home without needing to leave their homes. All India Organization of Chemists & Druggists, comprising of 7 lakh retail chemists and thousands of wholesalers, is obviously upset with the entry of online sellers into the pharmaceutical business. Many of their members running retail outlets in cities and urban centers are reporting sharp drop in sales and a large number of them are very small operators. The main complaint of AIOCD against the online traders was that they are operating in violation of D&C Rules which may harm the patients in the long run. The online traders now claim that they are operating within the rules and no violations are taking place. Therefore, they also need a space to operate within the limits of the law. The regulatory authorities are concerned over the sharp rise in internet sales of products and services in the country with no effective system to track their activities. A serious problem the patient community and regulatory authorities may face because of this new trading system is the possibility of routing of doubtful quality of medicines into the online. Such a possibility by unscrupulous operators cannot be ruled out. Therefore to have a regular monitoring on unethical and unlawful practices in the trade, a set of specific rules based on the Kamble committee needs to be introduced by the office of DCGI without any more delay. Pharmabiz