Following formation of a sub-committee to come up with a mechanism to regulate online sales of prescription drugs, officials associated with the development say that framing rules to govern online sale of drugs should also involve studying rules in other countries on how online pharmacy is governed there.
Though there are provisions and safeguards under the Indian Penal Code and Drugs and Cosmetics Act to deal with prevalent malpractices but there is also a need to explore other international regulatory bodies on how they are tackling the challenges in online pharmacy, the official said.
Drugs Controller General of India (DCGI) has formed a sub-committee to assess the feasibility of online pharmacy. This ensued from deliberations at the recently concluded 48th Drugs Consultative Committee (DCC) meeting.
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. 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 first meeting of the sub-committee headed by Maharashtra Food & Drugs Administration Commissioner Dr Harshdeep Kamble is likely to be held in the second week of August after receiving the copy of the 48th DCC meet proceedings by August first week. The other members of the committee are Karnataka drugs controller Raghurama Bhandary, along with the drugs controllers from Delhi, Odhisha and joint drugs controller, CDSCO, Dr S Eswara Reddy.
In the wake of information technology advancements, drug being an important segment in the e-commerce space was critical to the growing patient population who are looking for efficiency and convenience in access to medicines in a timely manner. Therefore, online pharmacy was on the top of the agenda of discussions at the just concluded DCC meet.
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) had also filed an FIR against the e-commerce sites few months back for online sale of prescription drugs. Explained a senior official, "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.”