Regulation/Guidelines

Draft of the new bill on New Drugs, Medical Devices and Cosmetics, 2022

  • 28th July, 2022

The new draft bill consists of a few new definitions such as clinical trials, over-the-counter drugs, manufacturers, cosmetics, medical devices, new drugs, bioavailability, investigational new drugs, imported spurious drugs, predicate devices and many others.

The new draft bill consists of seven chapters and nine schedules.

Chapter II of the draft contains information on the provisions made by the ministry to form a “medical devices technical advisory board.”

  • The board would include professionals with medical backgrounds and people with technical knowledge of medical devices.
  • It will also include the different officials from the Health Ministry, DRDO, Ministry of Electronics, biomedical experts, biomaterial and polymer experts, etc.

Chapter III of the draft includes information on the Import of Drugs and Cosmetics only in the public’s interest if the drug is being used in case of an emergency such as an epidemic or any natural disaster. If the drugs are found too risky for living beings or do not have any medical value as it claims, they can be prohibited.

  • The imported drug will be considered fake if it uses another name, resembles any other drug, the manufacturing company is fake, or does not have any active pharma element.

Chapter IV of the draft includes the expansion of clinical trials of drugs and manufacture, sales, and distribution of Drugs and Cosmetics.

  • If the drug licensing body has rational reasons to trust that the licensee has failed to comply with the acts, an “improvement notice” can be issued.
  • CLA will cancel the license if the licensee fails to provide satisfactory reasons within 14 days.

Chapter V of this bill includes Ayurveda, Siddha, Sowa Rigpa, Unani and Homeopathic Drugs under AYUSH, while chapter IV of the 1940 act covered these parts.

  • The government is planning to form a Scientific Research Board to backend the regulatory authority of scientific advances.
  • The scientific advances will help research, develop and innovate Ayurveda, Siddha, Sowa Rigpa, Unani and Homeopathic drugs.
  • This chapter will control their import.

Chapter VI includes medical devices and their import, sale, distribution, and clinical investigation, which were taken care of earlier by medical device regulation 2017.

  • The appointment of medical devices officer will also come under this chapter.
  • To conduct a clinical trial or investigation central licensing authority’s approval is needed.
  • This chapter also discusses the management and compensation part while conducting clinical trials.

Chapter VII is called miscellaneous, which deals with parts like DGCIDCGI appointment, allocating their duties, state drugs controller, and petitions under which any person has the right to approach central government against the decisions of the central licensing authority.

The draft also deals with the issue of online pharmacies, called e – pharmacies. It is stated that the union government is working on rules and regulations so that government can regulate the online sale of drugs and medical devices.

First, schedules consist of standards that must comply with for importing or manufacturing drugs for sale and distribution.

The second schedule consists of fees that need to be paid for the license, registration, certificate permission, and approval.

The third schedule consists of a list of drugs for which approval of the central license authority is required for issuing the license.

The fourth schedule consists of two categories:

  1. Misbranded drug category
  2. Non-standard quality drugs do not comply with the parameters in the bill.

The fifth schedule consists of Ayurveda, Siddha, Sowa Rigpa, Unani and Homeopathic books.

The sixth schedule consists of standards that must comply with to import or manufacture Ayurveda, Siddha, Sowa Rigpa, Unani, and Homeopathic for sale, distribution, and stock.

The seventh schedule consists of categories of Ayurveda, Siddha, Sowa Rigpa, Unani, and Homeopathic, for which approval from the central license authority is required for issuing the license.

As per this bill, the Adverse event report needs to be submitted by the person with a license for medical devices and periodic safety report at the prescribed frequency.

If any misbranded or adulterated drug or device is imported, customs have the right to detain it.

ChaptersDrug and Cosmetic Act 1940ChaptersNew drug, medical device and cosmetic bill, 2022
IINTRODUCTORYIINTRODUCTORY
IITHE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEEIITECHNICAL ADVISORY BOARDS, DRUGS LABORATORIES, MEDICAL DEVICES TESTING CENTRES AND CONSULTATIVE COMMITTEE
IIIIMPORT OF DRUGS AND COSMETICSIIIIMPORT OF DRUGS AND COSMETICS
IVMANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICSIVMANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS AND CLINICAL TRIAL OF DRUGS
IV APROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGSVPROVISIONS RELATING TO AYURVEDA, SIDDHA, SOWA RIGPA, UNANI AND HOMOEOPATHIC DRUGS
VMISCELLANEOUSVIIMPORT, MANUFACTURE, SALE, DISTRIBUTION AND CLINICAL INVESTIGATION OF MEDICAL DEVICES
VIVIIMISCELLANEOUS
Summary of Chapters in 1940 act vs 2022 bill

Summary

  • The Drugs, Medical Devices, and cosmetics Bill draft have separate definitions for medical devices, which complies with the medical device 2017 rule. In contrast, the 1940 Act has only a drug definition.
  • The draft bill has been present at the ministry’s site since 8th July. For the next 45 days, it is open for suggestions, comments, and objections from the public and investors.
  • The draft bill 2022 is an effort by the government of India to keep up with the new technologies and to replace the pre-independent Drugs and Cosmetics Act 1940.

Brief

  • When a new law is planned, it is presented as a bill.
  • When the bill is passed through governance (Legislature- President/Governor), it becomes an act.
  • Till now, medical devices were treated similarly to that medicine, with no separate rules for sales, manufacturing, distribution, or clinical trials.