Source: LiveMint.com, Oct. 17, 2017
New Delhi: The government plans to regulate the sale of medicines through online pharmacies, a proposal that is opposed by chemists on the grounds that online sales are illegal and easy availability of drugs can lead to their misuse.
The Central Drugs Standard Control Organisation (CDSCO), the regulator for pharmaceuticals and medical devices in India, and the health ministry have initiated discussions to frame a policy that will facilitate access to quality medicines and encourage more entrepreneurs to sell medicines online.
While as many as 50 online pharmacy start-ups sell medicines over the internet in India, the government’s proposal to regulate the market will give a stamp of official approval and remove uncertainties surrounding the legality of such sales.
The government plans to set up an electronic platform that will act as the nodal platform to monitor the movement of medicines. “The supply of any drug shall be made against a cash or credit memo generated through the electronic platform and soft and hard copies of memos shall be maintained by the licencee,” said the first draft of the proposal to regulate e-pharmacies. Mint has reviewed the document.
Officials working on the draft rules under the Drugs and Cosmetics Act have categorized drugs into five schedules ranging from medicines that have limited risk to those that have a greater potential to be abused. The third schedule carries all over-the-counter drugs; the fourth schedule will carry all prescription drugs; the fifth schedule will have antibiotics and anti-bacterial drugs; the sixth will deal with narcotics and psychotropic drugs; and the seventh will cover any medicines that do not fall under the other schedules. There are no first or second schedules.
It will however not be easy to buy refills and repeat orders online, according to the draft proposal. Antibiotics, antibacterial drugs and narcotics and psychotropic drugs shall not be dispensed “more than once” unless so prescribed.
“If the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals, it shall not be dispensed otherwise than in accordance with such directions,” said a government official privy to the development. At the time of sale, pharmacists will also have to maintain a record with the name and address of the seller and the date on which the prescription is dispensed.
The government is also considering that pharmacists after dispensing medicines stamp the prescription as “dispensed” and record the data for drugs or substances specified under the fifth or sixth schedule so that attempts at unauthorized use of the same prescription triggers an alert. For drugs under the fifth or sixth schedule, the patient should be registered on the website with their name, address and Aadhaar number.
To ensure safety, for drugs specified under the fourth, fifth and sixth schedules, the cash or the credit memo will contain the name of the doctor, their registration number and the patient’s address. “The rules are still under the discussion stage. We are planning to regulate the business in a phased manner after taking those in business on board,” another government official said.
Dharmil Sheth, co-founder of medicine delivery app Pharmeasy, said that rules are needed to enable a friendly environment for both online and offline retailers. “We cannot have different rules for every stakeholder. With the evolution of the internet and GST, there should not be any restriction on inter-state sale.”