Opinion: New "Drugs, Medical Devices and Cosmetics Bill 2022" Can Be Made Robust
It is heartening that the obsolete Drugs and Cosmetics Act 1940 is being replaced by the proposed New Drugs, Medical Devices and Cosmetics Bill (if enacted), 2022, and that suggestions and comments from the public and stakeholders are solicited.
The draft bill proposes new definitions for a clinical trial, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability studies, investigational new drug's and more. The bill also seeks to regulate online pharmacies and medical devices. It proposes penalties such as imprisonment and compensation in case of injury or death during clinical trials for drugs.
Here are some salient features and my comments on the draft Bill.
Section 1 (k): "clinical trial" means any systematic study of a new drug or investigational new drug or bioavailability or bioequivalence study of any new drug in human participants to generate data for discovering or verifying its clinical, pharmacological, including pharmacodynamics and pharmacokinetics, or adverse effects with the objective of determining safety, efficacy, or tolerance of the drug
Comments: The definition of 'clinical trial' is vague. It deviates considerably from the WHO definition.
WHO defines clinical trials as: "Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care Clinical trials are carefully designed, reviewed, and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.
Clinical trials usually involve participants from more than one medical or research institution, and often more than one country. As each country has its own requirements for clinical trials research it is possible that single trials could be included on more than one registry, and hence appear on more than one registry database. However, data on various clinical trial registries varies.
WHO's International Clinical Trials Registry Platform (ICTRP) links clinical trial registers globally to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups, and others. (Reference: Clinical Trials (WHO December 2019) Available on https://www.who.int/health-topics/clinical-trials#tab=tab_1 'Accessed on 11-07-2022)
Section 44 (2) (a): a drug shall not be deemed to be misbranded or adulterated or spurious or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below standard quality only by reason of the fact that there has been added thereto some innocuous substance or ingredient because the same is required for the manufacture or preparation of the drug.
Comments: The term "some innocuous substance or ingredient" needs elaboration. It is too vague and imprecise. It is prudent to specify the term with the name of 'innocuous substance or ingredient' to pre-empt misinterpretation of this clause.
Section 50: Every police officer shall be bound to assist a Drugs Control Officer demanding his assistance, (a) in the investigation and preventing the escape of any person who is suspected to commit an offense under this Act
Comments: This is commendable. Often threats to investigating officers are serious and with police protection, the drug control officers will be able to carry out duties fearlessly and effectively.
Section 56: Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes,- (a) any drug deemed to be adulterated shall be punishable with imprisonment for a term which shall not be less than ten years but which may extend to a term for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more.
Comments: This punishment is too mild. It should be capital punishment – nothing less. The offender can be prosecuted under IPC 120B, for being a party to a criminal conspiracy to commit a capital offence.
Section 62: Whoever uses any report of a test or analysis made by the Central Drugs Laboratory or by a Government Analyst, or any extract from such report, for the purpose of advertising any drug or cosmetic, shall be punishable with a fine.
Comments: This is laudable. Commercialization of the Central Drugs Laboratory was disallowed even in the Drugs and Cosmetics Act, of 1940.
Section 72 (1): No person shall by himself or by any other person on his behalf shall conduct any clinical trial in respect of a new drug, investigational new drug, bioavailability or bioequivalence study of any new drug, in human participants except under, and in accordance with, the permission granted by the Central Licensing Authority subject to such conditions and in such form and manner as may be prescribed.
Comment: This section should also have that no clinical trials are conducted on mentally deranged or retarded persons or those who are unable to make their own decisions.
Section 73: Where any participant is injured on account of his participation in the clinical trial the person permitted under subsection (1) of section 72 shall provide medical management to that participant.
Comment: In chronic disease, during a clinical trial a patient is responding to treatment, the study drug should be made available to him/her till such time the drug is commercially available.
Section 73 (3): Where the death of a participant is related to a clinical trial and is attributable to the study drug or on account of his participation in such trial, the person permitted under subsection (1) of section 72 shall provide to the legal heir of the participant, such compensation in such manner as may be prescribed.
Comment: This is vague. This needs to be tangible on the compensation – the exact compensation to be offered. The amount needs to be fixed.
Section 85: Chapter V shall apply to Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy drugs.
Comment: It is heartening that the new draft "Drug, Medical Devices, and Cosmetics Bill-2022" has brought the AYUSH medicines under the purview of the proposed Bill. However, there is no mention anywhere on heavy metal contamination of ayurvedic products has been mentioned. Toxicity associated with use of Ayurvedic products due to metal content is an increasingly recognized potential public health problem. This should be addressed.
Section 104: Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ayurvedic, Homoeopathic, Sowa Rigpa, Siddha, or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug.
Comment: Why are the punishments for offenders of allopath spurious and AYUSH spurious not identical? Both are playing with the safety and lives of humans.
No law is perfect. And that is why we constantly work to improve the law. A few patient-centered thoughts for the government's consideration.
Have a scientific and sophisticated technological and automated recall mechanism of drugs in place in case a drug needs to be recalled super-urgently for the safety of the patients. There are many such incidents in this century itself: cerivastatin, rofecoxib, and cisapride to name a few.
There is no mention anywhere of the need to standardize the AYUSH Products. This is an absolute necessity.
Along the lines of NIPER, we should have specialized institutes to educate students on Quality Control, Quality Assurance, and WHO-Good Manufacturing Practices.
Like in many countries, India too should not allow any company to market pharma products, unless they have their own manufacturing units.
Disclaimer: The views expressed in this article are of the author and not of the Medical Dialogues. The Editorial/Content team at Medical Dialogues has not contributed to the writing/editing/packaging of this article.
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