This article undertakes a review and assessment of regulatory issues in the Indian pharmaceutical industry. Understanding the regulatory process in this sector is extremely crucial due to the rapid and ongoing changes at the global level as well as at Indian drug regulatory landscape.
The Drugs and Cosmetics Act of 1940 and Rules 1945 have witnessed several amendments over the last few decades. In the year 2020, the Drugs and Cosmetics Rules was amended on a number of occasions and the key amendments are :
The Central Government has permitted the retail sale of drugs to the doorsteps of the consumer by any person holding a license in Form-20 or Form-21 under the Drugs and Cosmetics Rules, 1945 to sell, stock or exhibit or offer for sale, or distribute drugs by retail, intends to sell any drug including the drugs specified in Schedule H except,
The licensee can sell such drugs provided that any such sale specified in Schedule H shall be based on receipt of prescription physically or through e-mail and such sale of drugs shall further be subject to the following conditions:
The Central Government has notified that the drug, namely, hand sanitizer shall be exempted from the requirement of sale licence for its stocking or sale under the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, subject to the condition that provisions of condition (17) of rule 65 of the said Rules are complied with by the person stocking or selling hand sanitizers.
Rule 65 (17) of the Drugs and Cosmetics Rules, 1945 states that no drug shall be sold or stocked by the licensee after the date of expiration 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 Central Government has amended Rule 2 of the Drugs and Cosmetics Rules, 1945, to include term marketer under clause (ea).
The term “Marketer” means a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer under an agreement for the marketing of such drug by labeling or affixing his name on the label of the drug with a view for its sale and distribution.
Further, Rule 84D has been inserted which provides for an agreement for marketing. This rule makes it mandatory for every marketing company to enter into an agreement for the marketing of the drug.
Rule 84 E has been inserted to define the responsibility of the marketer. This equates the responsibility of marketer with a manufacturer for the quality of drugs and regulatory compliance.
Further, a sub-clause clause (xiii) in clause (1) Rule 96 has been inserted regarding the labelling requirement of drugs by marketer providing that :
This amendment comes into force wef 1st March 2021. However, the amendment does not provide any detailed procedure or guidelines on how a marketing company will maintain the quality of the drugs. So far, the marketing companies are marketing the drugs under contract manufacturing agreement whereby quality of drugs and regulatory compliances are the responsibility of manufacturers. The marketing companies are selling/distributing the drugs under wholesale license with storage conditions. In Not of Standard Quality cases, marketing companies were made co-accused for the failure of quality of drug and the plea under section 19 of the Drugs and Cosmetics Act, 1940 was available to the marketer if the drugs are obtained from a licensed manufacturer.
Now, In the light of a new amendment, a marketing company has to develop a mechanism to ensure the quality of drugs manufactured by a manufacturer and also comply with all regulatory compliances applicable to drugs.
The Central Government has amended certain provisions of part XB, Rule 122EA, 122G. Some of the key changes are:
The Central Government specifies the following devices intended for use in human beings or animals as drugs. All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception.
The Central Government has declared medical devices as drugs. These devices are covered by the definition of medical devices under Rule 3(zb) of Medical Devices Rules, 2017. The Central Government has notified devices to cover practically all devices intended to be used for diagnosis, mitigation, treatment, prevention of disease or disorder.
Further, the Central Government inserted Chapter IIIA to provide for the regulation of registration of these devices. The Medical devices referred to in sub-rule (1)of Rule 19 A shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose. The registration under this Chapter shall be on a voluntary basis for a period of eighteen months from the commencement of this Chapter thereafter it shall be mandatory.
Some of the examples of medical devices mentioned in Anexure of Rule 19 A are: