Every nation has a regulatory body that is tasked with enforcing laws and issuing directives to control the marketing of pharmaceuticals. Non-clinical research on a drug should be done after a lead drug molecule has been identified to ensure efficacy and safety. Clinical trials can then be carried out following the submission of an application to the relevant national authorities. Every pharmaceutical company at the time of medicine development and production; pre-clinical and clinical trials; ensuring safety, quality control, and checking standards require legal assistance. The only difference between them is the compliance factors and conditions. Let us discuss in detail the legal support needed by pharma companies in all these circumstances.
The main issues which must be considered while providing legal assistance are,
- What kind of legal support do these companies require?
- Is there any certifying authority for approving the legal submissions made by such pharma companies?
The laws applicable for the purpose of governing the pharma companies are:
- The Drugs and Cosmetics Act, 1940
- Medical Devices Rules, 2017
- New Drugs and Clinical Trial Rules, 2019
- CDSCO Good Clinical Practice Guidelines
- National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.
- For the purpose of Medicine development and production
The legal support that these companies require for the medicines development and production is: –
- To procure license from DCGI for the purpose of market entry
According to Section 122A of the Drug and Cosmetics Act, new medications that have been approved and used for a number of years in other countries are exempt from the requirement for clinical trials. According to the Drugs and Cosmetics Act 1940 and Rules 1945, all stages of clinical trials are necessary for drug compounds that are discovered in India. In accordance with Section 2.4(b) of Schedule Y of the Drugs and Cosmetics Act 1940 and Rules 1945, applicants for drug substances discovered in nations other than India are required to submit data from those nations, and the licensing authority may either require that he repeat all the studies or grant him permission to move on to Phase III clinical trials.
Before a drug product may be licenced for import or for the applicant to manufacture a new drug, Central Drugs Standard Control Organization must first see proof of its safety and effectiveness for use in people (CDSCO). The information necessary for approving an application to import or produce a novel drug for marketing is described in the regulations under the Drugs and Cosmetics Act of 1940 and its rules 1945, 122A, 122B, and 122D. Documents such as Generic name, Patent Status, Brief information of physio-chemical/biological status of the drug along with other technical information such as the Stability, Specifications, Manufacturing process, Worldwide regulatory status, Animal pharmacology and toxicity studies, Published clinical trial reports, Proposed protocol and pro forma, Trial duration, During master file and undertaking to Report Serious or Life-threatening Adverse Drug Reactions must be submitted to the Drug Controller General of India (DCGI). And the DCGI after verifying the same, if it is satisfied then it may grant the approval certificate.
- To comply with the guidelines and directions issued under the new Drugs and Clinical trial rules, 2019.
The next mandatory step is that the companies must follow the guidelines and directions issued under the new Drugs and Clinical Trial Rules, 2019. If these two requirements are fulfilled then the company can look forward for expansion of its market.
- For the purpose of pre-clinical and clinical trials
A clinical trial is basically an experiment conducted on humans to see and check the outcome and impact. For this purpose, the company needs certain legal backups to carry out this process without any hindrance.
The legal support that the company needs at the time of pre-clinical and clinical trial are:
- Authorisations from the concerned authorities
The concerned authorities are the independent ethics committee and the Drug Controller General of India. Academic clinical trials, which are ones that use an already-approved medicine but whose results are exclusively meant to be used for academic and research purposes rather than being submitted to the DCGI for drug approval, do not need DCGI approval. The academic clinical trial must still receive clearance from the institutions or a separate ethics committee. After authorizing the trial, the committee must notify the DCGI regarding the approval, if it is doubtful of the study’s nature. The DCGI’s clearance is assumed if no objection is received from the DCGI within 30 days.
The New Drugs and Clinical Trial Rules, 2019 stipulate the subjects involved in clinical trials; voluntary permission must be obtained. As part of the informed consent procedure, the subject must be informed about the fundamental components of the clinical trial and their right to compensation in the event of any harm or death which may result in the clinical trial. The New Drugs and Clinical Trial Rules, 2019 specify the format of the informed consent form, along with a checklist of the information that must be given to the subject during the informed consent process. The investigator of the clinical trial is required to document the subject’s consent in writing on the informed consent form. Audio-video recording is necessary for the informed consent process.
- For the purpose of quality, efficiency, safety controls and circulation of medicines
Manufacturers and importers of pharmaceuticals can have their facilities inspected by the DCGI, state licensing bodies for drugs, and drug inspectors. The authority may order the manufacturer or importer to recall the drug from the market if it is discovered to be harmful or in violation of the Drugs and Cosmetics Act, after giving the manufacturer or importer a chance to explain the situation. For new medications and experimental medical equipment, it is required to submit frequent safety updates and reports on adverse events (for a set length of time). Manufacturers and importers must abide by the standards on recall and quick alert systems for pharmaceuticals established by the Central Drugs Standard Control Organization (CDSCO) in the case of a mandatory or voluntary recall.
The complex regulatory regime governing the pharma sector can be adhered to only if the pharma companies comply with those procedural and statutory requirements. This strong compliance can be ensured only when the laws governing such industries are more stringent. Hence, these are the various procedures that require legal guidance which is essential for the day-to-day working of the companies.
Intern at Aggarwals & Associates, S.A.S. Nagar, Mohali