The sale of medicines through e-pharmacies violates the Drugs and Cosmetics Act and the Pharmacy Act puts the health and life of people at great risk
By Dr KK Aggarwal
A Delhi High Court bench of Chief Justice Rajendra Menon and Justice VK Rao has stayed the online sale of medicines by e-pharmacies across the country and directed the centre and the Delhi government to restrain their online sales as it is not permitted under the Drugs and Cosmetics Act, 1940, and the Pharmacy Act, 1948.
In October, the Madras High Court had granted an injunction restraining the sale of medicines and drugs online on a plea moved by the Tamil Nadu Chemists and Druggists Association.
One more petition is pending before the Delhi High Court which is seeking the closure of online pharmacies that are offering drugs and prescription medicines through websites.
The present judgment was passed on a petition filed by dermatologist Dr Zaheer Ahmed, who had “sought a ban on illegal sale of drugs and prescription medicines on the internet by online pharmacies”. The petition claimed that lakhs of medicines were being sold online through e-pharmacies in spite of a direction from the Drug Controller General of India to state Drug Controllers “to put a strict vigil on online sale of medicines in violation of the Drugs and Cosmetics Act and Rules thereunder, to protect the interest of public health”.
Ahmed submitted that easy availability of online drugs, without any checks by e-pharmacies, puts the health and life of people at great risk. The petition contends that the “illegal” sale of medicines on the internet could lead to drug abuse and misutilisation of habit-forming and addictive drugs. It also highlighted the serious consequences: “A large number of children/minor and people from uneducated rural background use internet and can be victims of wrong medication while ordering medicines online which are operating without a drug licence…The unregulated sale of medicines online will increase the risk of spurious, misbranded and substandard drugs being sold. Some drugs have psychotropic substances and can be easily ordered on internet and misused for criminal activities or drug abuse.”
There are no well-defined laws on this issue, though this year the government formulated some draft regulations for online pharmacies. But they are yet to be implemented.
Currently, the law does not permit the sale of online drugs. Scheduled drugs as mentioned in Schedules H, H1, X and E1 of the Drugs and Cosmetics Rules cannot be sold online as they require a valid prescription of a doctor. Online pharmacies may not abide by regulations relating to scheduled drugs and bypass them. The objective of Schedule H1 was primarily to check the indiscriminate use of antibiotics due to the rising incidence of multi-drug resistant bacteria, a serious public health issue worldwide. Unrestricted and unregulated sale of antibiotics via online pharmacies will defeat this very purpose.
In addition, dispensing of medicines by any person other than a registered pharmacist is a punishable offence under Section 42 of the Indian Pharmacy Act, 1948. Subsection 1 states: “…no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner”. Section 42(2) states: “Whoever contravenes the provisions of sub-section (1) shall be punishable with imprisonment for a term which may extend to six months, or with fine not exceeding one thousand rupees or with both.”
Section 10 of the Drugs and Cosmetics Act prohibits import of any drug that is not of standard quality or that is misbranded, adulterated, spurious or which requires a licence for import. Section 18C of this Act prohibits manufacture and sale of any drug without a licence.
The Act has no provisions for online sale of medicines or home delivery of medicines. Therefore, prescriptions submitted via fax/email may be fake and it could be difficult to verify their authenticity. Pharmacists are also not allowed to accept and dispense prescriptions that are brought in by children. Online pharmacies would provide easy access to controlled drugs or even street drugs to this vulnerable group. Many online pharmacies may be operating without a valid chemist licence. This increases the chances that drugs sold by such unlicenced pharmacies may be counterfeit, substandard or adulterated.
Medicines must also be stored properly as recommended by the manufacturer. Their exposure to high temperatures could diminish their efficacy and is a potential health risk. There is no way to check the storage conditions of drugs sold by online pharmacies. These pharmacies also offer drugs at a low cost or at discounted prices to lure customers.
Online pharmacies may also promote doctor substitution, which is unethical. Pharmacy laws in India do not allow a pharmacist to substitute a brand written by a doctor. They are also not authorised to change the potency of the prescribed drug even if the patient asks for it. Refilling of a prescription is not allowed by pharmacists unless authorised by the doctor. In addition, prescriptions of doctors are only valid in the state they practise in, according to the state medical council registration.
Online pharmacies may provide rebates and commissions to doctors to provide prescriptions based on online information that has been filled by the patient. This will make doctors vulnerable to malpractice suits. Regulation 6.4 of the MCI Code of Ethics prohibits doctors from giving or receiving any rebates or commissions.
Regulatory authorities continue to monitor a drug for any adverse effect even after it has been in the market.
If the safety/quality of a medicine comes under question or if it is potentially contaminated, mislabelled or improperly packaged, then they may recall it from the market even after it has been approved. Sometimes, the manufacturer may voluntarily recall a drug. If online pharmacies are permitted, drug recalls will become almost next to impossible.
Breach of confidentiality is another major concern. Online pharmacies may misuse personal and financial information of patients as well as doctors, leading to cases of identity theft and fraud.
Online pharmacies may also not have a mechanism to differentiate a modern medicine doctor from an AYUSH one. If online pharmacies are allowed, the National Pharmacovigilance Programme, initiated by the Central Drugs Standard Control Organisation under the Ministry of Health and Family Welfare, will become a futile exercise. This programme is not only meant for doctors but also for pharmacists.
In Martin F D’Souza vs Mohd Ishfaq dated February 17, 2009, Justices Markandey Katju and GS Singhvi of the Supreme Court listed precautions which doctors/hospitals/nursing homes should take: “No prescription should ordinarily be given without actual examination. The tendency to give prescription over the telephone, except in an acute emergency, should be avoided.”
The judgment remains valid today. When telephonic consultations are not allowed, how can internet pharmacies be justified? It is ironical that when a patient misuses this facility, medico-legal liability still falls on the doctor.
Despite the negatives, there are also some positives about online pharmacies. Medicines sold here are usually 30-40 percent cheaper. Then there is better availability of medicines. Like e-consultations, e-dispensing may be an answer for educated people, for refilling of prescriptions and for patients with an established relationship with a pharmacist.
One way to deal with this contentious issue is for the prescription to be uploaded by the doctor or the medical institution for delivery to the patient’s house. E-consultations are a norm in established doctor-patient relationships and similarly, in a pharmacy-patient established relationship. This can be done via a video call.
The need of the hour is to come out with a defined policy for both online consultations and online pharmacies.
—The writer is President, Heart Care Foundation of India, and President-Elect, Confederation of Medical Associations of Asia and Oceania