The process of approval of a new drug in India is a very intricate process, which should meet the necessary requirements. The new drug is a medication or therapy that has not been used earlier in clinical practice to treat a disease. A new drug that is marketed after the approval from the FDA. Getting new drug approval from the FDA is a multi-step process that takes years & money also. Here I am discussing the process of new drug approval in India.
When a company in India wants to manufacture/ import a new drug it has to apply to seek permission from the licensing authority (DCGI) by filing Form 44 (FORM 44 – Application for grant of permission to import or manufacture a new drug or to undertake clinical trial) and also submitting the data as given in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945. In order to prove it’s effectual and safety in the Indian population, it has to conduct clinical trials in accordance with the rule specified in Schedule Y and submit the report of such clinical trials in the specified format. But a terms is there in Rule- 122A (Application for permission to import new drug) of Drugs and Cosmetics Act 1940 and Rules 1945 that the licensing authority may waive certain trails if he considers that within the interest of public health he might grant permission for import of new drugs basing on the information of the trials done in other countries. Similarly another term in Rule- 122A that says that the clinical trials are waived within the case of new drugs that are approved and being used for several years in other countries.
Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says for those drug substances which are discovered in India all phases of clinical trials are required. Section 2.4 (b) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says that for those drug substances which are discovered in countries other than India; the applicant should submit the data available from other countries and the licensing authority may require him to repeat all the studies or permit him to proceed from Phase III clinical trials.
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Section 2.8 of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says that the licensing authority might need pharmacokinetic studies (Bio-equivalence studies) initial to indicate that the data generated in the Indian population is adequate to data generated abroad and then require him to proceed with Phase III trials. In summary, the exact requirements of Clinical trials may change from case to case and depend on the extent to which licensing authority is satisfied with its safety and efficacy.
Bio-availability and Bio-equivalence studies are needed by regulations to confirm therapeutic equivalence between a pharmaceutical equivalent test product and a reference product. For bio-availability / bio-equivalence studies Application in Form-44, Application in Form-12, Undertaking by the Principal Investigator (PI), Regulatory status of the Drug in India indicating strength and dosage, BA/BE Center approval copy issued by DCG (I), New Delhi, along with details of number of beds provided at the center (CRO), Sponsor’s Authorization letter, the study protocols, study synopsis, Informed Consent Form (ICF) or Patient Info Sheet (PIS) together with audio-visual recording system as per Schedule Y guidelines & copy of approval of protocol from the IEC, Copy of registration of Independent/ Institutional Ethics Committee (IEC) under Rule-122DD, Package insert/ prescribing information of the product, Published reports of Pharmacokinetic and Pharmacodynamics studies carried out in healthy subjects/ patients demonstrating safety and tolerability of the molecule and undertaking letter from the sponsor for complete compensation on any untoward condition are basically required for getting Drugs Controller permission.
In recent times, CDSCO has banned many unsafe and irrational Fixed drugs combinations formulations in India. Court cases and trial cases are undergoing for several such formulations by giant pharmaceutical companies since 2016.
In order to improve transparency, accountability, and efficiency in the processing of various applications submitted to CDSCO, it has launched an IT-enabled system “SUGAM” portal for online submission and monitoring of drug applications. Various forms like Form-41, Form 10, Test license, BE NOC, post-approval changes, test license all can be submitted through it. The entire process has emerged as a whole, a one-time process where applicants can continuously access their profile and the status of the application and may create the required amendments to their applications online.
CDSCO in recent years has undertaken many reforms in amending, upgrading, optimizing drug reforms of our country. At present though India has reasonably well-drafted legislation, namely, Drugs and Cosmetics Act, which was enacted in 1940 and Drugs and Cosmetics Rules, which were drafted in 1945. With increasing demand and supply of medicine in our vast country like India, in coming days it’s necessary for CDSCO with help of State Drug Controls to give more emphasis on the following features:-
• Post marketing surveillance
• Control on medical devices
• Control on diagnostics
• Control on nutraceuticals, feed supplements and herbal products
• Guidelines for promotional literature
• Promotion of rational use of drugs
• Guidelines for self -medication, regulation on Drug abuse.
• Monitoring of clinical trials and bio equivalence studies
• Monitoring of ADRs
• Interaction with consumers and handling of complaints
• Central nodal intelligence cum legal cell to coordinate the interstate activities
• Training of regulatory and laboratory personnel.
I hope the short overview comes helpful for my Pharma associates in understanding CDSCO for new drug approval.
References: www.cdsco.nic.in/ Disclosure:- The Author intends not to create any conflict of interest through the writing
Author: Debarati Bhattacharyya (Kundu) M. Pharm from Jadavpur University.
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