Nagpur : Taking note of rampant misuse of abortion pills in Maharashtra, Food and Drug Administration (FDA) has filed its first FIR against Amazon, multinational e-commerce portal. According to ‘e-pharmail’ from All India Drugs Action Network (AIDAN), 60 cases of on-line sale of abortion pills have been detected in Maharashtra in last couple of months. The portal is selling abortion pills on-line in all districts of Maharashtra including Nagpur. A city chemist, on the condition of anonymity said, “On-line sale of prescription drugs is illegal.
There are a number of websites where companies are aggressively promoting abortion pills. Young girls without knowing side effects of such pills are purchasing it from these portals. Despite various complaints to FDA authorities, no action was taken by the authorities.” The abortion pills are sold as MTP kit which is a combination of two drugs Mifepristone and Misoprostol. Both these drugs are included in Schedule H of Drugs and Cosmetic Act 1940. The MTP Kit can be taken only against the prescription of registered and qualified gynaecologist. “MTP Kit is a set of two essential abortion medicines -Mifepristone and Misoprostol which performs medical pregnancy termination (non-surgical embryo expel from womb) and should be taken only under the supervision and prescription of a gynecologist. MTP pills are recommended by physicians only for pregnancies that have not exceeded 63 days.
Medical abortion pills are prescription drugs that are different from emergency contraceptive pills generally advertised in media. They are taken between 7 and 9 weeks of pregnancy and cause the embryo to be expelled from the uterus,” said Harish Ganeshani, Pharmacist and owner of Kamal Medical Stores. A senior Drug Inspector mentioned, “Buying and selling of medicines on-line is illegal. As of today, there are no regulations in place for it. Though a policy is underway on regulating on-line sale of drugs, it has been a daunting task to bring to book the offenders as these on-line sales are facilitated either through courier services or transferred through off-line retail stores in the neighborhood having valid licenses.”
Maharashtra FDA got tip-off about illegal on-line sale of MTP Kits in Pune and Navi Mumbai. A T Nikhade, Joint Commissioner of FDA Maharashtra, Mumbai Headquarters told, “Joint Commissioner Pune Division has received the first complaint about on-line sale of MTP kit- with a trade name ‘Unwanted’. The supplier belongs to Debai in Uttar Pradesh. On the basis of the complaint, the first FIR has been filed at Wakad Police Station by Bhagyashree Yadav, Pune Drugs Inspector. FDA has sent a letter to Drug Controller of Uttar Pradesh and to Amazon to stop allowing on-line sale of medicines. FDA has also sought explanations from them.” Nikhade further said, “FDA is investigating two cases of on-line sales in Pune and Navi Mumbai. In both cases the supplier is same from Uttar Pradesh. In another case, complaint has been registered at Kamothe police station in Navi Mumbai, but no FIR has been filed against it”. Illegal stocking and selling of MTP kits without license is in contravention to the provisions of Section 18(c) of the Drugs and Cosmetics (D&C) Act, an FDA official informed.
The members of Maharashtra Registered Pharmacist Association (MRPA) were the whistleblowers in this issue. MRPA had recently ordered MTP pills on-line through Amazon and alerted Maharashtra FDA on receiving the pills. “This is the latest in the series of such cases where offenders used to stock and sell MTP kits in a clandestine manner without a license and trade it on-line. FDA has booked offenders under different sections of Drug and Magic Remedies (DMR) Act, Essential Commodities (EC) Act and D&C Act. An inter-state abortion drug racket with its network spanning across Gujarat and Delhi was the first case in the series unearthed by the FDA team two years ago in which drugs worth over Rs. 3 lakh were confiscated and three people were found contravening the provisions of the law under different sections of EC Act and D&C Act.,” AIDAN’s e-pharmail stated.
E-Pharmacy, a reality of future pharma trade
MAHARASHTRA FDA has decided to propose to the Union Government to prohibit on-line sale of MTP Pills. Many drugs which are included in Schedule X like tranquilisers, psychotropic drugs, narcotics and habit forming drugs have been prohibited through these portals, informed FDA Joint Commissioner A T Nikhade. Last year Union Health Ministry had come out with draft rules on sale of drugs by e-pharmacies with an aim to regulate on-line sale of medicines across India and provide patients accessibility to genuine drugs from authentic on-line portals. The draft rules on ‘sale of drugs by e-pharmacy’ state that no person will distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered. “It is mandatory for any person to apply for the grant of registration to the Central Drug Control Authority to conduct business of e-pharmacy. The person has to apply in Form 18AA through the on-line portal of the Central Government.
The draft notification says 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,” Nikhade added. The draft notification also stated that the supply of any drug should 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. Nikhade mentioned that rules have been proposed to ensure accessibility and availability of drugs to the people across India, after the rules are finalised, people will be able to get genuine drugs through these on-line pharmacies.
These pharmacies will be purchasing directly from the drug manufacturer so they will also be able to give 20-30 per cent discounts, thus benefiting the patients. It has been proposed that those who want to do on-line pharmacy will have to register with the Central Drugs Standard Control Organization (CDSCO), the country’s apex drug regulator and central licensing authority. Now those who want to operate e-pharmacies, only need to take one licence in any state. They can sell drugs all over the country even if they have one licence.
The draft rules suggested that the premises from where the e-pharmacy business has been conducted should be inspected, every two years, by a team of officers authorised by the Central Licensing Authority, with or without the experts in the relevant field or the officers authorised by the concerned State Licensing Authority. It would binding on the e-pharmacies to deliver the drugs in the specific time that will be told to the patient during the time of purchase while the e-portals are mandatory required to have 24/7 call centres. The registration issued to any person for e-pharmacy will remain valid for a period a three years from the date of its issuance and a renewal of registration will have to be done in case it wants to continue. No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose, the draft said. There are also provisions of suspension and cancellation of registration of the e-portal if the latter contravenes any provision of the Drugs and Cosmetics Act, 1940.