Tamil Nadu pharmacy traders approach Court against online pharmacies

Committee to look into regulations for e-pharmacy to submit report in four weeks' time, says government

Tamil Nadu Chemists and Druggists Association (TNCDA), an affiliate of the trader's organisation All India Oranisation of Chemists and Druggists (AIOCD), has filed a petition with the Madras High Court seeking the Department of Health and Family Welfare, Government of India and the drug regulators to block all websites in the country selling prescription medicines till the license are granted to them to sell medicines through online.

The association, which has over 30,000 members in retail and wholesale pharmaceutical trade in the state, also said that it has to be heard by the government before enacting any new law related to online pharmacy.

When the matter came up for hearing, along with a public interest litigation related to online pharmacy, the Assistant Solicitor General informed the Court that the report of the Committee appointed to look into the regulations for online pharmacy is still under formulation and will be placed before the Government within four weeks.

Based on this, Chief Justice Sanjay Kishan Kaul and Justice R Mahadevan posted the matter for directions on October 18, 2016.

In its petition, TNCDA argued that the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rule, 1945, and the Pharmacy Act, 1948 were written prior to arrival of computers and the subsequent amendments also added no provision related to the online sale of medicines.

"Hence as per Drugs and Cosmetics Rule, it is not permitted to ship, mail or door delivery of the prescribed medicines and hence no provision for selling of medicines on-line," it said.

If the e-pharmacies are not approved or regulated properly, the medicine sold online may be not up to the standards or even counterfeit drugs, it argued. It said that there are around 3500 sites which are dealing with the online medicines and distributing the same in whole country and online pharmacies are not required as more than eight lakh community pharmacies are licensed to sell medicines across the country.

The Rules and Provisions needs to be fulfilled before commencing and running for any of the pharmacy store within country. The Drug and Cosmetics act & Rule shall be amended to permit the acceptance of documents and records in electronic storage and applicability of Information Technology., as at present carbon copies of sales invoices are to be preserved for two years.

The association sought the Court to issue direction to block the link of all such websites from India who are selling Schedule H and schedule X medicines, which are to be disbursed only against prescription, in violation of Rule-65 & 97 of Drugs & Cosmetics Rules, 1945 till the license are granted to sell medicines through online and pass further or other orders as may be deemed fit.

TNCDA also argued that web sites located in each state and licensed by the designated authorities and list of approved e-pharmacies must be made available in public domain and regulated by special division in the Drug control department.