Tag Archives: drugs

Ministry of Health and Family Welfare- Draft Amendment Rules to amend the Drugs and Cosmetics Rules, 1945.

The Ministry of Health and Family Welfare vide its notification dated 26th February 2019 has introduced the draft amendment rules to amend the Drugs and Cosmetics Rules 1945 inviting suggestions/comments from the public. The changes proposed are summarised below.

An additional condition has been imposed on certain applicants who wish to obtain licences under the Drugs and Cosmetics Rules, 1945. The applicants shall be required to furnish an undertaking stating that no similar brand names or trade names exist in the market which will lead to any deception or cause confusion in the market. This condition has to be satisfied by the applicants for obtaining the following licences:

  1. a loan licence[i] or renewal of a loan licence from the authority in Form 25, or a licence/ renewal of the licence for the manufacture of drugs included in Schedule X in Form 25-F.
  2. a licence for repacking of drugs, the drugs other than those specified in Schedule C and C(1), or renewal of the licence in Form 25-B.
  3. a loan licence for the manufacture of drugs for sale or for distribution of drugs other than the drugs specified in Schedule C, C(1), and X in Form 25A.
  4. a licence (in Form 28, 28-B or 28-D) to manufacture (or renewal thereof) for drugs specified in Schedules C and C(1), [excluding those specified in Part XB and Schedule X].
  5. a loan licence/ renewal licence (in Form 28A or 28DA) to manufacture for sale or for distribution drugs specified in Schedule C and C1 excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs.

Sources:

  1. Explanation to Section 69 (A) (1) of the Drugs and Cosmetics Act, 1940- loan licence means a licence which the Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 25.
  2. Draft Rules – http://egazette.nic.in/WriteReadData/2019/198746.pdf

 

Draft rules for  Operation of E-Pharmacies in India

Regulatory Update: Ministry of Health and Family Welfare

The Ministry of Health and Family Welfare vide its notification G.S.R. 817 (E) dated 28th August, 2018 introduced a draft to amend the Drugs and Cosmetics Rules,1945 (“Rules”). These rules have been currently released in the public domain for comments and suggestions from various stakeholders. The draft rules shall come into force after their final publication in the Official Gazette.

The draft rules make provisions for sale of drugs by e-pharmacy. As a result Part VI-B is inserted into the Rules. Some of the notable changes brought by the draft rules are as follows:

Registration and Customer Support: The draft rules make it mandatory that no person shall sell, stock, exhibit or offer for sale drugs through e-pharmacy portal unless registered. Further an e-pharmacy registration holder shall have a facility for customer support and grievance redressal for all stakeholders. The customer support and grievance redressal shall operate for not less than 24 (twenty four) hours for all 7 (seven) days of a week. Also the facility shall also have a registered pharmacist in place to answer the queries of customers through customer helpline.

The draft rules also mandate that the information which is received by the e-pharmacy registration holder from the customer by way of prescription or any other means shall not be disclosed to any other third person.

Data Localisation: Also as per the draft rules the e-pharmacy portals have to be established in India through which they are conducting their business and shall keep the data generated localised. The draft rules clearly stipulates that under no means the data generated or mirrored through e-pharmacy portal shall be sent or stored by any means outside India.

Application for Registration for e-pharmacy: Any person intending to conduct business of e-pharmacy shall apply for registration to the Central Licensing Authority in Form 18AA through the online portal and along with an online fee of INR 50,000 (Rupees Fifty thousand only) and the documents specified in Form 18AA.

Registration: The detailed conditions for registration for an e-pharmacy registration holder are laid down in rule 67-M. Some of the conditions include being compliant with Information Technology Act, 2000 and the rules therein, details of the patients to be kept confidential, the supply of drugs being made against cash or credit memo generated through e-pharmacy portal, informing the Central License Authority in the case of any change in the constitution of the firm taking place, uploading, e-pharmacy activities not being carried out with respect to any drug referred in e Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), tranquilizers and the drugs as specified in the Schedule X of the Rules.

Certain information needs to be disclosed on the e-pharmacy portal such as the registration issued, constitution of the firm including the details of directors, partners, official logo of the e-pharmacy, details of the logistics service provider, return policy etc.

Periodic Inspection: The draft rules also provide the detailed conditions for registration for an e-pharmacy and provides for a period inspection of the same. The premise where the e-pharmacy business is conducted shall be inspected every 2 (two) years by the Central Licensing Authority.

Procedure for distribution of sale of drugs through e-Pharmacy: It is the duty of the registered pharmacist on the behalf of e-pharmacy registration holder to verify the details of the patients, registered medical practitioner and arrange for dispense of the drugs.  Further in cases of e-prescriptions the same shall be uploaded on the e-pharmacy portal and shall be kept in record by the dispenser.

Validity of registration and renewal: The registration issued to any person shall be valid for a period of 3 (three) years and shall be renewed subject to a fee of INR 50000 (Rupees Fifty Thousand).

Further the draft rules stipulate that no e-pharmacy shall advertise any drug on radio or television or internet or any print media. And in case where the drug supplied is not of standard quality or misbranded or a spurious drug a complaint can be made to the State Drugs Controller as the.

Finally under the draft rules the Central Licensing Authority and the State Licensing Authority shall have the power to monitor the data with regard to drugs available with e-pharmacist, types of drugs offered for sale, supply channels etc. to ensure compliance with the Drugs and Cosmetics Act, 1940.

(Online available at: http://egazette.nic.in/WriteReadData/2018/189043.pdf )