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The Union ministry of health and family welfare has issued draft of the Drugs (Sale and Distribution) Rules, 2017 aiming at removing ambiguity on regulations to facilitate sales of drugs online.

The ministry issued the draft rules in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) in supersession of Part VI, Schedule N, Form 19, Form 19A, Form 20, Form 20A, Form 20 B, Form 21, Form 21A, Form 21B, Form 20F, Form 20G and Form 26C contained in the Drugs and Cosmetics Rules, 1945. It was recently released by the ministry seeking suggestions from stakeholders. 

The draft comprises of six chapters covering process to obtain drug selling license, regulation of sale of drugs through e-pharmacy, roles of licensing authority, essentials of prescription, submission of data on electronic platform, inspection for verification of compliance, conditions for grant of license to sell drugs by wholesale or distribute the same by a motor vehicle, suspension or cancellation of licenses, digitalisation of forms etc.

These rules shall be applicable in respect of the drugs as defined in clause (b) of the section 3 of the Drugs and Cosmetics Act, 1940. If there is any inconsistency between these rules and the Drugs and Cosmetics Rules, 1945, the provisions of these rules shall prevail over the Drugs and Cosmetics Rules, 1945. From the commencement of these rules within a period of two years all existing establishments holding licences for sale and distribution of drugs under the Drugs and Cosmetics Rules, 1945 may apply online for registration to the central licencing authority.

Applicants are required to pay a fee of Rs. 1 lakh for grant of registration of e-pharmacy to sell, exhibit or offer for sale of drugs in one state. Additional fee of Rs. 50,000 need to be paid for grant of registration of e-pharmacy to sell, exhibit or offer for sale of drugs in each additional state. One needs to pay Rs. 1,000 for registration of licencee on electronic platform which will be set up by the central government to facilitate online sale of drugs.

As per the draft, the rules pertaining to registration of e-pharmacy and audit of the electronic platform for ensuring compliance with D&C Rules will be enforced by central licencing authority.Supply of drugs by any e-pharmacy shall be made only through the electronic platform specified in rule 20. The e-pharmacy registered under rule 32 shall supply drugs within the state or states where it got registered.

The applicants seeking registration of e-pharmacy need to furnish details of identity proof, registered pharmacists, compliance to good distribution practice, helpline facility for counselling the patient with respect to drug usage. 

The e-pharmacy shall mention the following details on its website,- registration certificate in Form S-8, constitution of the firm, official logo of the electronic platform, details of the service provider delivering the shipments, return policy, name of the registered pharmacist under whose supervision the drugs are dispensed, contact details, and procedure for lodging complaints etc. on his website. The e-pharmacy shall provide a link to the web page of the registry of e-Pharmacies provided on the electronic platform on its website.

The web servers of the registration holders shall be located in India through which they are offering services and mining the data thereof. Registration holder shall comply with relevant provisions of Information Technology Act 2000 and Rules thereunder. Registration holder shall carry out e-pharmacy only to the place located in India. The drugs mentioned under Fourth Schedule (H), Fifth Schedule (H1) or Sixth Schedule (X) shall be supplied by or under the personal supervision of a registered pharmacist. No drug shall be sold or stocked by the registration holder after the date of expiry of potency recorded on its container, label or wrapper, or in violation of any statement or direction recorded on such container, label or wrapper. 

The registration holder shall maintain an inspection book in Form S-6 to enable an inspector to record his impressions and the defects noticed. The supply of any drug shall be made by registered pharmacists against prescriptions of registered medical practitioners. The licencees need to maintain record containing the following particulars:- name, address and sale licence number of the licencee, serial number and date of the cash/credit memo, and the name of the drug, quantity, batch number, date of expiry and name of the manufacturer, name and address of registration holder.Registration holder shall not carry out e-pharmacy with respect to the drugs covered under the categories of the narcotic, psychotropic, tranquilizers, and Schedule X drugs.

Registration holder shall effect sale only from the respective state from where it has received the order and expected it to be delivered through licensed retail chemist of that state. 

On receipt of prescription, the e-pharmacy shall verify the details of the patient, based on his unique identity as may be prescribed by the central government from time to time, dispense the drugs as per the instructions of the registered medical practitioner, if not already found dispensed. If the drugs were already dispensed or in case of any discrepancy with respect to the patient details, the e-pharmacy shall reject the request for the supply of the drugs. The details of the drugs dispensed including the patient details shall be recorded on the electronic platform. In case of e-prescription, the prescription shall be uploaded on the electronic portal and a hard copy thereof shall be kept in record by the dispenser.

Registration certificate issued in Form S-4 shall remain valid in perpetuity, unless, it is suspended or cancelled by state licencing authority. No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose.

Source :- Laxmi Yadav, Mumbai
Wednesday, October 04, 2017