E-commerce is here to stay, with marketing agencies like Amazon and Flipkart becoming household names. Sales in India are predicted to go from Rs 31800 crores in 2014 to Rs 105120 crores by 2018. With greater penetration resulting from increased internet speed and reach, the idea has truly taken root.
However there was cause for alarm when the concept was transposed to e-pharmacy by Snapdeal recently, and before that by Medplus, Apollo, and Bookmeds Medicals. The Maharashtra FDA promptly registered an FIR against Kunal Bahl the CEO of Snapdeal for selling prescription drugs online. Two Snapdeal godowns in Goregaon and Bhiwandi were raided after they found that the site listed more than 45 drugs that violated provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.“We sent a notice to Snapdeal and in spite of their written commitment to delist the drugs from their website, we found they continued to exhibit for sale drugs”. Snapdeal maintained that they were only a platform where medicines are sold, denying responsibility for what gets sold. Such arguments do not wash because health issues and medicines cannot possibly be put on par with selling shoes and shirts.
On the one hand e-pharmacy does have a few benefits. It would be a boon for the elderly and those confined to the house, to go online and have their medication delivered to the house, particularly drugs for long term treatment. Long queues are avoided, payments can be more convenient and drugs could be cheaper because retailer margins are eliminated. However there are objections.
Firstly it contravenes the Drugs and Cosmetics Act, whereby apart from OTC products, drugs can be sold only against a valid prescription from a physician qualified to do so, and dispensed by a pharmacist also duly qualified to do so.
On-line pharmacies by-pass both these requirements and will only add to the tremendous Indian problem of self-medication and abuse, for example, of antibiotics and all its squeal. The Global Antibiotic Resistance Partnership in 2011 estimated that 20% of all antibiotics sold in Delhi were without a prescription.
Secondly there are issues based on the international experience. Internet pharmacies are a known source of illegal recreational drugs, spurious drugs and stolen drugs. There is also the risk of prescription abuse by using the same prescription numerous times. India has acquired the dubious reputation of being the world’s largest source of spurious drugs as recorded by customs seizures. The US FDA in a test case ordered a prescription drug online and received an envelope with an India postmark with some unlabeled white tablets which on analysis bore no resemblance to what was ordered.
In fact in 2013, it shut down 1600 online pharmacies, took action against 9600 websites and seized $41 million worth of illegal medicines.At the same time dismissing e-commerce in pharmacy off hand would be throwing out the baby with the bath water, and we have a lot to learn from the US experience. On Feb. 12, 2001, Ryan Haight, a young boy in San Diego, USA, died from an overdose of Vicodin, a cough mixture he bought online for a “high”. His mother pursued the matter with the local senator and eventually George Bush passed the “Ryan Haight Act”.
The highlights of this act are: it amends the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. A “valid prescription” is defined as one that is issued for a legitimate purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient. The Controlled Substances Act is extended to online pharmacies and the issuance of prescriptions over the Internet. It imposes registration and reporting requirements on online pharmacies. Penalties were increased up to 10 years imprisonment for first time offender and 20 years for second offenders. In case of serious bodily injury or death, the punishment can even extend to the death sentence. In addition, the US federal authorities entered into collaboration with Google to block illegal online pharmacies from appearing in Google search results.
In India there are no dedicated laws for online pharmacies. “Bricks and mortar” pharmacies are governed by the Drug and Cosmetics Act 1940, Pharmacy Act 1948 and Indian Medical Council Act 1956. Even with these laws in place, pharmacies are known to flout them by making nearly all drugs available as OTC products without insisting on prescriptions. Laws related to e-commerce are defined under the Information Technology Act, 2000. Without a specific law along the lines of the US “Ryan Haight Act” there are tremendous dangers in permitting this trade. Self-medication will increase, resulting in misuse. Quality control will disappear; inappropriately stored drugs, expired drugs, counterfeit and even harmful adulteration will wreak havocIn short without adequate legislation in place, every existing law relating to the manufacture, storage, prescribing, dispensing of drugs, ensuring compliance with counselling and follow-up care stands to be violated and rendered impotent.
(Dr Gladstone D’Costa is the Chairman, Accreditation Committee and member, Executive Committee, Goa Medical Council.)
