Madras high court stays online sale of medicines

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IN THE HONOURABLE HIGH COURT OF JUDICATURE

AT MADRAS

The TamilNadu Chemists & Druggists Association
Rep by its General Secretary
Mr.K.K.Selvan
Having office at
D-36, 8th Floor,
‘D’ Block, Halls Towers, 33,
Halls Road, Chennai,
Tamil Nadu 600008 …PETITIONER
VS
1. THE UNION OF INDIA
Through the Department of Health & Family Welfare,
Room No.348, A Wing,
Nirman Bhavan,
New Delhi – 110011.

2. THE STATE OF TAMILNADU
Rep by its SECRETARY
Department of Health and Family Welfare,
Fort St. George
Chennai.

3. Central Drugs Standard
Control Organization,
Directorate General of Health Services,
Ministry of Health and Family Welfare,
Government of India,
FDA Bhavan, ITO, Kotla Road,
New Delhi – 110002.

5. The Drugs Controller,
Drugs Control Department
359, Anna Salai,
Thenampet,
Chennai-6 …Respondents

AFFIDAVIT OF MR.K.K.SELVAN
I, Mr.K.K.Selvan S/o.K.A.Kaliappan, Hindu, aged about 46 years, and having office at D-36, 8th Floor, ‘D’ Block, Halls Towers, 33, Halls Road, Chennai, Tamil Nadu 600008, do hereby solemnly affirm and sincerely state on oath as follows:-

1. I am the petitioner herein. I am the elected General Secretary of The TamilNadu Chemists & Druggists Association and I am empowered to file this writ Petition on behalf of the Association and I am well acquainted with the facts and circumstances of
this case. I filed a writ petition in WP No. 28325 of 2016 before this Hon’ble Court praying for a Writ of Mandamus to block the link of all such websites from India who are selling Schedule H,H1 & schedule X medicines in violation of Rule-65 & 97 of Drugs & Cosmetics Rules, 1945 till the license are granted to sell medicines through online. The said writ petition came up for hearing before this Hon’ble Court and it was represented on behalf of the Respondents that the draft rules are under process and the said writ petition is also pending.

2. I state that The TamilNadu Chemists & Druggists Association (TNCDA), is a Society registered under the Societies Act under Sl.No. 423 of 1997. It is a representative body of nearly 30,000 members engaged in pharmaceuticals retail and wholesale trade. The TNCDA is affiliated to the All India Organization of Chemists and Druggists (Regd) (AIOCD), looking to it for guidance and direction, and also supports and works in close co-ordination with the apex all India body. The prime objective of TNCDA is to protect the interest of our members and the general public and ensure a constant flow of distribution of the best quality of medicines in the prescribed rates at every nook and corner of the country. We also ensure that there is a good rapport with Industry and Government bodies at State level.

3. I state that the members of this body are professionally working as Pharmacy Distributors, Stockiest, General Wholesalers and Retail Chemists throughout the state of TamilNadu. The basic purpose of this body is to streamline the distribution pattern of Pharma Distribution, so that an unbroken chain of life-saving and essential drugs is maintained throughout the nook and corner of the state. The day to day problems of the retailers, wholesalers etc, are taken up by this body through respective District Associations and interactions are made with the relevant quarters, like Government Agencies, Pharmaceutical Manufacturers and Manufacturing Organizations, Professional Forums etc. to mitigate the problems of the members and to update their professional knowledge with the help and guidance of the AIOCD- an All India Organization to which we are affiliated, All the TamilNadu District Associations, numbering around 31 districts, are affiliated to this TamilNadu Chemists and Druggists Association.

4. I submit that the online shopping of consumer products are Popular in India, since it is very easy to purchase the said product online from various sites. People find it convenient option as the said products get available at the door step. Like other products nowadays medicines are also being sold through internet which is illegal. There is a great risk in purchasing medicines from unlicensed online stores, because they may sell fake, expired, contaminated, not of standard quality, habit forming drugs, wrong medicines or otherwise unsafe products that are dangerous to patients and may put their health at risk.

5. I submit laws for Pharmacies in India are governed under from Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rule, 1945 and Pharmacy Act, 1948. These laws were framed prior to arrival of computers and India does not have any law or provisions to regulate and for online sale of medicines. The Drugs and Cosmetics Act 1940 and Rules 1945 made there under was amended many times in the past years 1955,1960,1962, 1964, 1972, 1982, 1986,and 1995 and 2008 and no provision has been made to utilize information technology or amended to on-line sale of medicines. The medicines are not simple items of commerce, they are an essential component of patient’s health and they must be administrated to patients in a timely manner as prescribed by the Registered Medical Practitioner and such drugs are provided under the direct supervision of qualified person (Pharmacist) for the benefit of patients. The medicines are issued to consumer as per prescription by/under the supervision of a qualified pharmacist at retail medical shop/pharmacy. The medicines are issued only as per specific prescription and dosages as prescribed by Registered Medical Practitioner. The retail chemist or consumer has no choice to substitute any other medicine or strength of prescribed medicine. The present community pharmacies are licensed to dispense the prescribed medicines under a supervision of a qualified pharmacist and dispensed at the premises which is licensed premises to sell medicines as per Rule 65 of Drugs and Cosmetics Rule, 1945. 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. The drugs of scheduled and non-Scheduled category are available online on different sites & distributed in our country. As on today there are more than 3500 sites which are dealing with the online medicines & distributing the same in the whole country.

6. I submit that the internet has changed the way we live, work and shop. The growth of internet and e- commerce has made it possible to compare the price and buy products without even leaving home. But when it comes to buying medicine on-line, it is important to be very careful. Some web sells medicines that may not be safe to use and could put patient’s health at very risk and sometimes it will lead to death. There is every possibility that if E- pharmacy is not approved and regulated properly, the medicine sold on-line may be
. They are counterfeit drugs

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