Topics Covered:
Government policies and interventions for development in various sectors and issues arising out of their design and implementation.
Centre stops online sale of medicines
What to study?
For Prelims: About DCGI.
For Mains: Need for regulation and significance of e pharmacies.
Context: Drugs Controller General of India (DCGI) has asked all states and Union Territories to prohibit sale of drugs by online pharmacies as per the Delhi High Court order.
Background:
The Delhi High Court in December 2018 had ordered the ban on sale of illegal or unlicensed online sale of medicines till the government drafts rules to regulate e-pharmacies.
How online pharmacies are currently operating in India?
Online pharmacies are operating in the country without a drug licence as there are no rules framed for the sector.
What’s the issue now?
The PIL filed in the court observed that the online illegal sale of medicines would lead to a drug epidemic, drug abuse and misuse of habit forming and addictive drugs.
The PIL also said that since there was no mechanism to control the sale of medicines online, this puts health and lives of people at a high risk and affects their right to a safe and healthy life under Article 21 of the Constitution.
In response, E-pharmacies told the Court that they do not require a license for online sale of drugs and prescription medicines as they do not sell them, instead they are only delivering the medications akin to food-delivery app Swiggy.
Other risks that exist in buying drugs online:
- Supply of fake and illegal drugs.
- Abuse on account of fake or forged or no prescriptions.
- Lack of verification of the ultimate user.
- Unhealthy competition.
- Abuse of critical health data generated online.
- Mishandling during transport.
Draft rules:
Ministry of health and family welfare, in September 2018, issued a draft notification on the sale of drugs by E-Pharmacies. It sought to amend the Drugs and Cosmetics Rules to enable registration of the e pharmacies and monitoring of their functioning.
Highlights of the Draft:
- All the e-pharmacies have to be registered compulsorily with the Central Drugs Standard control organisation.
- Psychotropic substances, habit-forming medicines like cough syrup and sleeping pills, schedule x drugs will not be sold online.
- Apart from registration, the e pharmacies have to obtain a license from the State government to sell the medicines online.
- The application of registration of e-pharmacy will have to be accompanied by a sum of Rs 50,000 while asserting that an e-pharmacy registration holder will have to comply with provisions of Information Technology Act, 2000 (21 of 2000).
- The details of patient shall be kept confidential and shall not be disclosed to any person other than the central government or the state government concerned, as the case may be.
- The supply of any drug shall be made against a cash or credit memo generated through the e-pharmacy portal and such memos shall be maintained by the e-pharmacy registration holder as record.
- Both state and central drug authorities will be monitoring the data of sales and transactions of e pharmacies. Any violation of rules the registration of e-pharmacies will be suspended, and it can be cancelled too.
- The premises from which e-pharmacy is operated regular inspections will be conducted every two years by the central licencing authority.
Need for regulation:
Ministry of Health, Central Drugs Standard Control Organisation and an expert committee appointed by the drug consultative committee have already concluded that the online sale of medicines is in contravention of the provisions of Drugs and Cosmetics Act, 1940 and the other allied laws.
Still lakhs of drugs are being sold on internet every day. Some of the drugs/medicines contain narcotic and psychotropic substances and some can even cause antibiotic resistant-bacteria which is a threat not only to the patient but to the humanity at large.
Sources: the Hindu.
