The Drugs Controller General of India is considering tracking online sale of medicines to ensure patient safety. In December 2015, the drug regulator had issued a circular stating that sale of drugs over the internet is in contravention of the Drugs and Cosmetic Act, a legislation which governs the sale of drugs in India. The Act says that all medicines have to be dispensed under the supervision of a registered pharmacist.
However, after declaring e-pharmacies illegal, the regulator also instituted a sub-committee to examine online sales of medicines.
In January this year, the sub-committee under the chairmanship of Dr Harshdeep Kamble, commissioner of Maharashtra Food and Drug Administration, submitted its report recommending the creation of a central portal to monitor movement of medicines sold online.
Online pharmacies have been increasingly popular in India because they offer discounts and the convenience of getting a doorstep delivery of medicines. But doctors are worried about the absence of a pharmacist in dispensing medicines.
At present, online pharmacies in India are governed by the Information Technology Act, the Drugs and Cosmetic Act, the Pharmacy Act and the Indian Medical Act.
A prescription for medicines ordered is mandatory, except for sale of over-the-counter products. The drugs are classified under various schedules under the law and the requirement of the nature of prescriptions vary.
“Right now selling medicine online is illegal,” said Kamble. “Until the government creates amendments in the present laws or creates a new legislation allowing the sale of drugs online, e-pharmacies are illegal.” Kamble refused to divulge details of the committee’s recommendations.
The Indian Internet Pharmacy Association president Prashant Tandon said, “Indian e-pharmacies are operating under the ambit of law.” He insisted that e-pharmacies are just technology platforms connecting the buyer – a patient – and seller – a chemist – like any other e-commerce platform.
The Drugs Controller General of India Dr GN Singh said that state regulators will have to take a call whether an online pharmacy operating in their jurisdiction is is doing so legally. “A statutory provision needs to be made,” said Singh, insisting that e-pharmacies need proper checks and balances fearing the huge potential of exploitation.
Offline versus online
A brick and mortar pharmacy requires a licence from local authorities before selling medicines. There is no provision for online platforms selling drugs to apply for licences. E-pharmacy operators interviewed by Scroll.in maintained that they do not need a licence since the pharmacies from which the drugs are sourced for sale online are licenced.
Dadha said that online pharmacies are complementary to existing brick and mortar pharmacies.
The All India Organisation of Chemists and Druggists that has about eight lakh chemist members, has protested against e-pharmacies. “It is not in the interest of public,” J Shinde, president of the All India Organisation of Chemists and Druggists, said that online sale of drugs a contravention of the existing laws. “Online pharmacy is a good weapon for the drug mafia to approach the youth.”
Shinde reasoned that “tampering of prescriptions” is already common and will only increase with online sales allowing easy access of habit-forming drugs. “Now, the pharmacist knows the doctors practicing in his locality and can easily pick any abnormality in the prescription but in online that is not possible,” said Shinde.
Tandon who also runs an e-pharmacy called 1mg said that current online pharmacies denies that there is any imminent danger of this happening. According to him, online sales of habit-forming drugs only occurs in international trade where drugs sold are shipped between countries. “This is not the case, e-pharmacies are focusing on medicines meant for treating chronic conditions such as diabetes and hypertension,” he said.
Tracking sales of online drugs will help eliminate the risk of abuse, said Singh.
Pharmacist as gatekeeper
A pharmacist is responsible for dispensing the right medicines and even counseling a patient about side-effects and dosage. In the online space, where the medicines are delivered at the patient’s home, there is no possibility of an interaction between a patient and a pharmacist.
The Drugs and Cosmetic Act requires that a pharmacy should be run under the continuous personal supervision of a registered pharmacist whose name should be displayed conspicuously on the premises.
Dadha maintained that this issue is easily resolved for e-pharmacies. “In case a buyer has any doubts, it can be clarified by submitting a query online,” he said.
Doctors are sceptical about online counseling for medication. “Abuse and misuse of drugs is already a concern,” said Dr Nikhil Datar, president of the charitable trust Patient Safety Alliance. “Human interference is mandatory especially in India where medicines look alike.”
According to Dr Dhaval Shah, co-founder of PharmEasy, most e-pharmacies including his have safeguards like hired pharmacists who monitor prescriptions uploaded. “The online platforms are just facilitating a pharmacist who will dispense the drug which is delivered at the customer’s home.”
Companies operating e-pharmacies say that prescriptions uploaded on the website are scrutinised. Pradeep Dadha, founder of Netmeds Market Place, an e-pharmacy which has close to one million registered users, said that 30% of prescriptions uploaded on the platform are not “validated” because they do not pass this scrutiny fr valid prescriptions.
But as SV Veeramani, past president of the Indian Drug Manufacturers’ Association pointed out, misuse of prescriptions is easy. “Same prescription can be reused by the patient to buy medicines from different online platforms,” he said.
Another challenge is to ensure the safe-delivery of the medicines. As some companies such as Dadha’s ship medicines across states in India the possibility of spurious drugs entering the system arises. “In online you do not know where the medicine is coming from and where is it going,” said said Shinde. “What if spurious and sub-standard medicines are delivered to patients? Tracking will help do post-mortems [of patients who might die due to consumption of spurious drugs] but the damage will already be done.”
What worries some doctors most is the sale of prescription medicines like antibiotics. India is already fighting against antibiotic resistance for the irrational use of antibiotics for which both doctors and patients are to be blamed.
The Indian Drug Manufacturers’ Association has already communicated to the government that prescription medicines should not be permitted for online sale. “In other countries, only over-the counter drugs are permitted for online sale,” said Veeramani.