The Union government, in its New Drugs, Medical Devices, and Cosmetics Bill of 2023, has proposed that the country’s apex drug regulatory body — the Central Drugs Standard Control Organisation (CDSCO) — be empowered to regulate the manufacture of drugs or cosmetics.
It will essentially take the place of state drug regulators, according to the revised draft of the Bill that has been sent for inter-ministerial consultations.
The draft New Drugs, Medical Devices, and Cosmetics Bill was first placed in the public domain in July last year, seeking feedback from stakeholders.
The Union Health Ministry and the CDSCO received several comments from the stakeholders, which were incorporated and the Bill revised accordingly by the ministry before sending it for inter-ministerial consultations.
Sates will only regulate sales
States will, however, continue to regulate the sale of drugs, cosmetics, and medical devices, according to the revised draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023, which seeks to replace the existing Drugs and Cosmetics Act of 1940.
At present, almost every district in the country has state drug control offices to administer provisions relating to the manufacture and sale of drugs and cosmetics.
Concern over India-made drugs
In the backdrop of questions being raised about the quality of Indian drugs over the past few months, the Central government wants control over manufacturing of drugs and cosmetics in its own hands.
In the past six months, there were three cases where an Indian pharmaceutical company has caused harm to the people.
On Friday, 3 February, Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops allegedly linked to vision loss in the US.
Demand from the pharma industry
Hyderabad-based Bharat Biotech’s chairman Dr Krishna Ella, in statement on 5 February, had said that all state drug regulatory bodies should be merged with the CDSCO to ensure “one quality, one standard” for drugs made in the country.
The whole of Indian pharmaceutical industries cannot be sullied for a handful of cases, he said. “Even in Western countries, some of the companies are penalised on quality issues,” he explained.
“There should be a single regulatory framework in India. All state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation (CDSCO), and that will solve the problem,” Ella said.
“But somewhere a political decision and commitment are required for this,” he said.
Niti Aayog backs Bill
During the consultations on the draft Bill, government think tank NITI Aayog endorsed the newly-introduced provision of giving the powers to the CDSCO to issue manufacturing licences for drugs and cosmetics instead of the state regulators.
It said this will ensure uniform and effective implementation of the law and it implies a huge change with a with a central licensing authority overseeing all manufacturing.
At presently, manufacturing activities relating to drugs and cosmetics are regulated by the respective state governments through their drug control organisations.
Once the proposed bill is passed by Parliament, all the powers of the state governments relating to regulation of manufacture of drugs and cosmetics will go to the Centre through the CDSCO.
For effective implementation of the newly-introduced provision and regulation of manufacture of drugs and cosmetics by the CDSCO, it has to be strengthened accordingly in terms of infrastructure and manpower.
Further, the provision of taking permission to operate an e-pharmacy has been removed and replaced with the words “central government may regulate, restrict or prohibit the sale, stocking, exhibiting or offer for sale or distribution of any drug by online mode by notification” in the draft Bill”.
Besides, regulations for the conduct of clinical trials for new drugs and medical devices have been brought under the draft Bill.
Currently, the conduct of clinical trials for new drugs and medical devices and the provisions for compensation for injury or death on account of participation in clinical trials, medical management of the trial participants, regulation of the ethics committee, etc, are governed by the New Drugs and Clinical Trials Rules, 2019.
Also, medical devices are treated as drugs and there is no separate definition for these.
The proposed bill provides for regulation of clinical trials of new drugs, investigational new drugs, and an ethics committee.
“However, in the interest of public health or extreme urgency of drugs, the central government is empowered to make provisions for the central licensing authority to waive the requirement of conducting clinical trial for manufacture or import of new drugs or investigational new drugs in the country,” the draft bill read.
“Where any participant is injured on account of his participation in the clinical investigation, the person, sponsor, clinical research organisation, any other organisation or investigator permitted under sub-section (1) of section 116 shall provide medical management to that participant,” it stated.
Currently, all these provisions are there in the rules but now, these have been proposed in the bill, an official said.
The draft Bill has a separate chapter on AYUSH drugs, which proposes to regulate sowa rigpa and homeopathy for the first time. The existing act regulates only ayurveda, unani and siddha drugs and cosmetics.
The draft Bill has introduced various definitions or provisions, such as bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over-the-counter (OTC) drugs, adulterated cosmetics, etc, for more clarity and smooth functioning and implementation, an official said.
The penalties for offences related to import of drugs and cosmetics have been enhanced appropriately in the draft Bill.
Under the existing rules, there is no provision to impose penalties, such as imprisonment, on the erring firms or people for a failure to provide compensation to the participants in the clinical trials for both drugs and medical devices.
(With PTI inputs)