D&C Rules need revamp as there is no clause of compensation for ADRs: regulatory experts
Taking into account the four main components of regulator, industry, trade and patient/consumer in a medicine value supply chain, the Drugs and Cosmetics (D&C) Rules, 1945 and D&C Act, 1940 needs an urgent revamp as there is no clause of compensation for ADRs in patients, according to drug regulatory experts.
Section 85 (2) of the D&C Rules, 1945 stipulates that a licensee or manufacturer whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.
Section 85-I provisions for cancellation and suspension of licences. The licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules made thereunder.
Voicing his concern about the patient’s safety, a former senior drug control official said that the Section 85 has no provision of holding the manufacturer liable in the event of an adverse drug reaction (ADR) or Serious Adverse Event (SAE). There is no safeguard or compensation mechanism for the patient who buys and consumes the medicine.
Maharashtra Food and Drug Administration (FDA) recently booked 12 people in a counterfeit drug death case that was reported in Mumbai based Saifee Hospital in November last year. A 55-year-old patient died at Saifee Hospital after an adverse drug reaction (ADR) suspected to be linked to a fake injection – Inj. Orofer FCM, following which the Maharashtra FDA initiated a thorough investigation into the matter.
An ADR can be defined as a harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product.
The Union ministry of health and family welfare (MoHFW) had in July 2022 released the draft of New Drugs, Medical Devices and Cosmetics Bill, 2022, a comprehensive legislation with provisions to regulate medical devices, clinical trials and online pharmacy, among others in order to keep pace with changing needs, times, and technology as against the pre-independence legislation of the D&C Act, 1940.
The Central government had constituted a committee to frame the Bill. Suggestions, comments and objections were invited from the public and stakeholders with regard to the draft Bill, within a period of 45 days from the date of issue of notice. The legislation has not been enacted as yet.
The draft includes provisions through which the Central Licensing Authority (CLA), can in public interest, abbreviate, defer or waive offer such pre-clinical and clinical data requirements for approval of such new drug, relating to life threatening of serious diseases or rare diseases or diseases of special relevance to the country, in such manner as may be prescribed.
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