DRUGS, MEDICAL DEVICES AND COSMETICS BILL, 2022

I. INTRODUCTION

The Ministry of Health and Family Welfare (“MHFW”), on 8 July 2022, released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”) for
objections, comments, and suggestions from the public and from relevant stakeholders.1 The Bill will replace the existing Drugs and Cosmetics Act, 1940
(“Act”). The provisions of the new regulation will be in addition to, and not in derogation of any other law for the time being in force. The Bill comprises
regulations on online pharmacies, clinical testing, medical devices, Ayurveda, Sowa Rigpa, Unani, and Homeopathy, and their respective advisory boards.

II. KEY CHANGES FROM THE ACT

• Ayurveda, Sowa Rigpa, Unani, Homeopathy, bioavailability study, clinical trials, over-the-counter drugs, cosmetics, medical devices,
investigational new drugs, proprietary medicine, and imported spurious drugs.
New definitions

• Provisions for regulating and licencing e-pharmacies for the sale and distribution of drugs in the market (i.e) no person can himself or
by any other person or on his behalf, sell, stock, exhibit, distribute any drug by online mode except as prescribed.
E-Pharmacies • Presently, there are no provisions or rules in place which regulate e-pharmacies.

• The Central Government can, in the interest of the public, restrict the manufacture, sale, or distribution of drugs (including import of drugs)
(a) in an emergency borne out of an epidemic;
(b) natural calamities;
Restrictions (c) if the usage involves any risk to human beings or animals; (or) if the drug does not satisfy its therapeutic values.

1 Drugs, Medical Devices and Cosmetics Bill, 2022, Accessed at: https://main.mohfw.gov.in/newshighlights-97.

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 • Compulsory licences from the central licencing authorities are required, for any clinical trials / investigations of medical devices and drugs.
• Participants of the trials are protected by providing medical management and compensation for injury related to such clinical trials.
Clinical
• The legal heirs of such participants will be compensated in case of death and/or failure to deliver.
Trials

• 'Medical Device Centres' are to be set up by the Government which are similar to Drug Labratories.
Medical Devices

• Specific provisions are included to encourage employing modern science and technology for the development of drugs and medical
devices in Ayurveda, Sowa Rigpa, Unani and Homeopathy.
• Establishment of a scientific research board which supports the regulatory body on methods and safety procedures associated with
Ayurveda the development of drugs and devices under this section.

• Creation of Medical Devices Technical Advisory Board (“Board”) to advise the Government.
• The Board would be diverse and would include representatives from different fields, for example: medical professionals, officials from
Board the MHFW, Department of Atomic Energy, etc.

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III. PENALTIES

The Bill includes penalties for multiple offences in the form of imprisonment and fines of varied nature. Some of the key provisions are:

•Penalty in the form of imprisonment for minimum of ten years which may be extended to life, and fine of minimum ten lakh
rupees or three times the value of drugs confiscated whichever is more can be charged for importation of drugs or cosmetics if they
Penalty for Import of are adulterated, spurious, and deemed to not meet the standards and quality as required.
Drugs or Cosmetics

•For offences related to manufacture of drugs which are adulterated, spurious, and fail to meet the standards and quality, penalties
in the form of imprisonment for minimum of ten years which may be extended to life and fine of minimum ten lakh rupees or three
times the value of drugs confiscated whichever is more. For Cosmetics, the penalty is limited to imprisonment for a year which may
Penalty for
Manufacture, Sale etc. be extended to three years and fine of minimum two lakh rupees.
of Drugs and
Cosmetics.

•Penalty for conducting clinical trials without permission includes a fine of three to five lakh rupees and adequate compensation.
Penalty for Conducting
Clinical Trials without
permission.

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IV. COMMENTS AND ISSUES ON THE BILL

¨ The definition of ‘clinical trial’ significantly deviates from World Health Organization (“WHO”) standards and has been left extremely vague and open to
interpretation. As per WHO, ‘clinical trial’ refers to “any research study that prospectively assigns human participation or groups of humans to one or
more health-related interventions to evaluate the effects on health outcomes.” This definition includes Interventional Trials as well as Phase I to Phase
IV trials.

¨ Good manufacturing practices, which are the standard and acceptable criteria, have not been covered.

¨ The bill fails to provide any regulation on post-marketing surveillance for medical devices. In practice, implants tend to remain within patients’ bodies for
years and have long term harmful effects.

¨ Further, the bill lacks provisions for implementing mandates for companies to recall devices or medicines in case of issues concerning such devices and
medicines.

¨ Lastly, the bill only provides a recommendation to the Government to formulate regulations for the operation of e-pharmacies but fails to provide any
guidelines for the same.

V. CONCLUSION

The implementation of the Bill by the Government is long overdue. There has been increasing demand from medical professionals and policymakers calling
for legislation that takes the current conflict and technology into context by bridging the lacunae in law. Yet, the Bill remains vague and requires clarification
by the Government, which hopefully will be provided prior to its implementation.

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