India’s drug regulator Drugs Controller General of India, after consultation with expert committees and public representation, has issued an order banning the online sale of medicines, which has been on a rise in the country for the last couple of years with e-commerce boom.
The Central Drug Standards Control Organisation (CDSCO) order cautions that the online trade of drugs and pharmaceuticals grossly violates rules of existing Drugs and Cosmetics Act, under which the pharmacy trade is regulated and monitored at present.
"An analysis of the representations made by public and other bodies revealed that serious concerns have been raised about public health such as gross violation of Drugs and Cosmetics Act and Rules endangering human life, rendering pharmacovigilance (post marketing reports on adverse drug reactions etc.) machinery ineffective, rendering drugs recall impossible , compromise of storage conditions, danger of online sales of controlled substances, encouragement of drug addiction among youth, etc.,” the CDSCO order said.
The order signed by joint drugs controller of India, Eswara Reddy, was issued on December 30 and has also informed all state drug regulators to keep strict vigil on online sale of medicines and take action against those indulge in online sales of medicines in violation of the law in the interest of public health.
Online pharmacies have been proliferating India after the fast emergence of e-commerce culture in India. A number of online pharmacy companies have registered and started operations, taking advantage of the absence any legal restriction to this model as the existing laws related to pharmaceutical manufacturing and marketing in India were drafted decades ago.
While the government had recently initiated action against some of the big e-commerce sites, including Flipkart, for selling medicines without pharmacy license, the government has been deliberating on controlling the proliferation e-pharmacies, which primarily operate the model of aggregators of sales through licensed pharmacies.
The Drugs Consultative Committee, the technical advisory body of the CDSCO, had earlier deliberated on the new trend of online pharmacies and appointed a dedicated sub-committee under the leadership of commissioner of Maharashtra Food and Drug Administration to study the merits and demerits.
While this committee is currently in the process of inviting views from technical experts and other stake holders, the CDSCO said in its order that since the safety and efficacy of medicines dispersed under online model is a serious health concern, it could not wait till the final views of the subcommittee on this.
While the concerns raised by the government are important in the absence of better regulatory mechanism to deal with the online sale of medicines, there are also views from the e-commerce industry and consultants that the order to ban the e-pharmacies would hurt the growth.
"The CDSCO seems to have taken interim action based on representations made. This will certainly be a dampener from an e-commerce perspective," said Anand Mehta, partner of industry consultant and legal firm Khaitan and Company.
BW Businessworld had in an earlier column, examining the dangers of online sale of medicines in a country like India, where spurious and counterfeit products are rampantly available, had cautioned that the mushrooming e-pharmacies may encourage circulation of unsafe products, and online trade in medicines should be allowed only when the country is ready with an updated drug regulatory mechanism.
BW Reporters
Unnikrishnan is currently Senior Associate Editor with BW Businessworld at its Mumbai Bureau. During his two decades long journalistic career, he has received several media awards and recognitions. His articles on healthcare, life sciences and intellectual property rights (IPR) have been republished by several international blogs and journals.
