To import or manufacture a new drug, a company has to seek permission from DCGI, the licensing authority by the filing Form 44 and submitting the requisite documents under Plan Y of the Drugs and Cosmetics Act 1940 and Rules 1945. Further, to prove its efficacy and be trustworthy among its consumers, it has to undergo clinical trials in consonance with the guidelines. However, certain drugs are prevented from trials if it is considered in the light of public interest and is improved in another country where it has already undergone trials and is approved.
MAJOR RULES AND REGULATIONS TO CONSIDER FOR DRUG APPROVAL IN INDIA:
Drugs and Cosmetics Act,1940 and Rules,1945
Narcotic Drugs and Psychotropic Substances 1985
Drugs Price Control Order 1995
Consumer Protection Act 1986
Factories Act 1948
Law of Contract (Indian Contracts Act,1872)
Monopolistic & Restrictive Trade Practices Act-1969
ICH GCP Guidelines
ICMRGuidelines Registry of Trial
NEW DRUG APPLICATION:
This is an application for seeking permission from FDA for manufacturing a new drug. Prior to permission, the company has to obtain preclinical and clinical test reports for a comprehensive study of the drug.
After the receipt of the NDA, the agency undertakes technical screening to ensure relevant data has been inserted in the application for formal review. There are 3 consequences of the review, i.e., either not approved while explaining the deficiencies of the drug. Secondly, it is approvable, subject to the correction of minor deficiencies. Finally, it is approved.
DRUG CONTROLLER GENERAL OF INDIA:
Clinical Research functions under the direct supervision of DCGI. DCGI therein runs under the guidelines of CDSCO, whose main functions are to regulate product approval, and clinical trials, introduce new drugs,s and import licenses of new drugs.
PHASES OF CLINICAL TRIALS
There are 4 phases of clinical trials, namely:
Pre-clinical study- trials on animals such as mice, rabbits, monkey
Phase-I- Human pharmacology trial to analyze the safety and tolerability
Phase-II- Exploratory trial to estimate efficiency and short term side effects
Phase III- confirmatory trial to confirm therapeutic benefits
Phase-IV- post-marketing trial to do further research.
1. DATA COLLECTION:
Certain information has to be submitted along with the application for evaluating the efficiency and safety of drugs. During the Phase-I and phase-II of a clinical trial, first, the company is introduced with a brief description which includes its functions and administrative headquarters, their respective addresses, manufacturing facilities offered, and a comparison with the regulatory and intellectual-property status of other countries. It also must include the patent status in India
and other countries.
A specific drug that is to be approved must have its own product description including the therapeutic class to which it belongs. It must include details of product development, strain details, information on substances used, and general product information. During the phase III of clinical studies, all the above-mentioned data has to be deposited along with the proposed Phase-III studies and non-clinical data.
2. REQUISITES FOR PERMISSION OF NEW DRUG APPROVAL:
The applicant has to submit Form 44, under the provisions of the Drugs and Cosmetics Act,1940 and rules,1945. The first module shall comprise documents subjected to the regional requirements. The second one has to include a pharmaceutical brief, including the mode of action and proposed clinical utility of the drug. It shall be brief and include the proprietary name, non-proprietary name of the common name, company names, strengths, weaknesses, company names, route of administration, and proposed indication.
Further, information on the quality of the drug has to submit in the format as prescribed in guidance M4Q. This comprises quality documents, chemistry documents, and controls of drugs. Information on safety has to be submitted in the format f M4S to show an analysis of non-clinical data imperative for the safety of medicinal products. Another vital part is the efficacy of the proposed drug, which has to be submitted in the format described in Guidance M4E to give a summary impression of clinical efficacy and clinical safety of the drugs.
3. PREPARATION OF QUALITY INFORMATION:
It should have the entirety of the accompanying data:
Characterization, both physical and biological
Drug product name
Controls of drug product
APPLICATION FOR PERMISSION TO CONDUCT TRIALS:
This application shall be granted by Licensing Authority in Form 44, in writing. The application for trials on humans shall be done through Form 44 along with a fee of fifty thousand rupees and other requisites as per Schedule Y Exploratory trials shall be conducted on the basis of data derived from the Phase-I trial, along with a sum of twenty-five thousand rupees. Confirmatory trials to be made from the data derived from Phase II and shall be accompanied by a sum of twenty-five thousand rupees.