The government plans to regulate the sale of medicines through online pharmacies, a proposal that is opposed by chemists because online sales are illegal and the easy availability of medicines can lead to their misuse.
The Central Medicines 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 170 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.
Officials working on the draft rules under the Medicines and Cosmetics Act have categorized medicines 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 medicines; the fourth schedule will carry all medicine order medicines; the fifth schedule will have antibiotics and anti-bacterial medicines; the sixth will deal with narcotics and psychotropic medicines, 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 medicines, narcotics, and psychotropic medicines shall not be dispensed “more than once” unless so prescribed.
“If the medicine order contains a direction that it may be dispensed a stated number of times or at stated intervals, it shall not be dispensed otherwise than by 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 medicine order is dispensed.
The government is also considering that pharmacists after dispensing medicines stamp the medicine order as “dispensed” and record the data for medicines or substances specified under the fifth or sixth schedule so that attempts at unauthorized use of the same medicine order trigger an alert.
To ensure safety, for medicines 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.
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