Against the backdrop of cases of illegal online sales of prescription drugs through e-commerce sites in India, Drug Controller General of India (DCGI) office is now planning to study the existing regulations internationally to come out with a set of rules on online pharmacy. The issue is likely to be taken up in the forthcoming Drug Consultative Committee (DCC) meeting likely to be held in June this year.   

The free availability of prescription drugs from online retail sites has added to the growing heap of questions on the lack of adequate regulatory framework for the e-commerce sector.

Explained Dr G N Singh, DCGI, "There should be no compromise on safety of patients when we take into account that there is an online distribution system in place which today is not approved legally and hence is unacceptable. There are currently provisions and safeguards under the Indian Penal Code and D&C Act to deal with prevalent malpractices but we are planning to explore other international regulatory bodies on how are they are tackling the challenges in online pharmacy."

This will help, according to the drug regulator in curbing the currently prevalent illegal practice of irrational use of drugs through self-medication, more so, as it has become a global phenomena.

The drug distribution is currently being regulated at the state level by the health departments for detecting such cases and taking action. FDA officials, however, pinpoint that there is a need for a proper regulatory mechanism for online pharmacy.

Gujarat Food and Drug Control Administration (FDCA) has till date detected three such cases of online sales of prescription drugs and spurious medicines. The regulator has taken legal action on the websites under the provisions of D&C Act and Narcotic Drugs and Psychotropic Substances (NDPS) Act. In one such case, spurious medicines worth Rs. 7 lakhs were being sold online by a firm based out of Surat.

As per the Section 18 (c) of Drugs and Cosmetics Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of prescription of a doctor only.

Rule 65 prescribes the procedure to be adopted by the medical stores while selling the prescription drugs and under which the prescription from the registered medical practitioner is necessary for sale of Schedule H drugs under the Act.
 
Maharashtra Food and Drug Administration (FDA) has recently filed an FIR against the Snapdeal.com directors at the Panvel police station in Raigad district for online sale of prescription drugs following a raid on e-commerce site's office in Mumbai. The state regulator has also written to the Drug Controller General of India (DCGI) on the matter.

FDA team raided the Snapdeal premises after the receipt of information that various drugs including the prescription drugs are being offered for sale and sold through Snapdeal.com.

According to a Snapdeal official, "The traders selling online are retailers and distributors, small and medium business and large brands who typically sell offline, too. Snapdeal acts as an intermediary between the seller and the buyer of the products listed on the platform. Though we invest significantly in educating sellers on engaging in fair and safe sales on the platform and consequences of selling inappropriate products, at times, sellers end up listing such products. Upon being notified of any such products, we delist the products and take appropriate action against such seller.”