RECENT CHANGES IN REGULATORY ASPECTS OF CLINICAL TRIALS IN INDIA

 

Introduction:

India with well-trained professionals and many pharm companies these conduct more clinical trials, it depends on cost reduction and increase pace and production of all R and D phases and also consists of growth impact to the favorable regulatory climate for conducting a clinical trial in India. Various institutions are guiding the role of clinical pharmacists in India, it includes the DCGI (drug controller general of India) DOB (Department of Biotechnology) ICMR (Indian council of medical research) CBN (Central bureau narcotics) RCGM (Review committee of generic manipulation) GEAC (Generic engineering approval committee).

Regulations in India:

         Regulation with mechanisms and explaining the quality and integrity of data collected in clinical trials are maintained for the safety and well-being of the participants.

Regulatory mechanisms:

              Regulation is a mechanism used to control a system it helps to terminate the effect of disturbance and makes the whole system sensitive to disturbances reducing its effect on overall system performance.

Types:

Law: A law is conducted by enforcing or controlling authority.

E.g.: the drugs and cosmetic act 1940 and rules 1945.

Regulations:

An interpretation explains to implement a law schedule.

E.g.: Y-schedule is the Indian regulation for clinical research issued by CDSCO headed by DCGI, FDA Bhawan, and Delhi.

Guidelines:

         It explains the regulations which a not legally binding and may not be universally accepted. it is accepted as the industry standard.

E.g.: Indian council of medical research (ICMR) guidelines, and Indian GCP guidelines.

Pre-requisites of conducting clinical trials in India:

           Permission from the drug controller general India (DCGI) Approval by the ethics committee. The number of drugs approved also increased in 2015.after three-tier reviews depending on the cases. Analyzing this we can say that scenario of clinical trial approval has improved DCGI compared to 2014 and earlier.

Number of Clinical trials approvals in 2014  and  2015 by DCGI

S.no	Therapeutic area	Approved in 2014	Approved in 2015
1.	Analagesics, anesthetics &  rhumatology	8	1
2.	Antibiotics	4	0
3.	Cardiology&  renal	14	7
4.	Dermatology & Allery	3	8
5.	Gastroenterology & hepatology	2	5
6.	Metabolism & endocrinology	15	18
7.	Nephrology	4	1
8.	Neurology	7	3
9.	Oncology	23	27
10.	Hematology		5
11.	Ophthalmology	8	5
12.	Orthopedics	2	1
13.	Pulmonary	6	4
14.	Radio –diagnostic	0	0
15.	Infectious disease	9	13
16.	Others (probiotics, A/BE studies in healthy patients, in genetic disorder, hormones, surgery)	11	10
Total	Approvals	116	108

Indian regulations for clinical trials

              India's clinical research industry follows the drugs and cosmetic act, of 1940 recently the Indian regulations underweight progressive changes as new drugs and clinical trial rules, 2019. Clinical trials have been registered with the Indian council of medical registry in India (CTRI) compliance with ICH-GCP guidelines is mandatory which describes quality assurance and safety of the subject, SUGAM portal for the submission of SAEs has digitized the clinical trials safety reporting methods and Indian clinical trails are moving in the right direction in terms of automatic approvals, speedy review and response to approvals and overall streamlining digitization and globalization of the Indian regulatory aspects of the clinical trials.

Current drug regulatory procedures:

            Currently, clinical trials are regulated by schedule Y of the drug and cosmetics rules 1945. After an amendment to was D and C act in 2005. In the present condition schedule, Y was revised to bring Indian regulations and accepted the international procedures and definitions.

• Definitions of phase 1-4 tails and eliminate the phase lag
• Procedures for notifying the changes in protocol 

The central drug standard control organization under the ministry of health and family welfare describes the safety, efficacy, and quality of drugs, cosmetics, diagnostics, and other devices in India, ministries that regulate other various aspects of drugs such as the poisons act 1919, the pharmacy act 1948, the drugs and magic remedies1954, narcotic drugs and psychotropic substances toilet preparations act (excise duties) 1956, drug price control order act 2000 and factories act 1948.

                     Indian clinical trials are negatively affected by noncompliance with regulations and reports from unethical trials. Indian government authority has been recently issued by establishing the regulating mechanisms for clinical trials. it is based on in-depth investigation and non-governmental organization (NGO) involvement. 1n 2019 further advanced clinical research in India routine implementation for the clear and valid process for clinical trials. India clinical trial regulations have been conducted on several studies and other articles are published some other evaluation perceptions and opinions related to professionals such as research coordinators, associates and managers have been neglected have these professionals' awareness and opinions on NDCT rules.

They play an essential role in addressing reporting and documenting ethical clinical trials for the investigators and ethical clinical committee and are mainly involved in the vulnerable populations in India this review aims are explained changes in regulations in clinical trials in India newly changed rules impact awareness issued by 2019.

 Conclusion:

On 30th September 2013, the Supreme Court’s hearing on the petition filed by the Indore-based group, Health Forum, brought 162 ongoing clinical trials in India to a halt as it asked the government to give details about its trial approval process. This was a major setback but a dim ray of hope still exists as 76 new trials 64 of which were ongoing and 12 of which are yet to begin are approved last year as on August 2014 based on the three-parameter assessment of risk versus benefit to the patients, innovation vies-a-visa existing therapeutic choice and unmet medical need in the country as directed by the Supreme Court.

References:

1.    Imran M, Ngami AK, Rashid MF, Tabriz S, Shah MA. Clinical research regulation in India-history, development, initiatives, challenges, and controversies: A still long way to go. Journal of Pharmacy & Bio allied Sciences. 2013; 5(1): 2-9.

2.    Good Clinical Practices: Guidelines for Clinical Trials on Pharmaceutical Products in India [Internet] New Delhi: CDSCO; 2001. [Accessed on 19.7.13]. Central Drugs Standard Control Organization, Directorate General of Health Services, India. Good Clinical Practices for Clinical Research in India. Available from: http://cdsco.nic.in/html/gcp1.html . [Google Scholar]

3.    Major hurdles cleared for clinical trials in India: Experts. Available from: http://articles.economictimes.indiatimes.com/2015-07- 23/news/64773370_1_clinical-trials-suneela-that-iscr

4.    Indian GCP Guidelines. 2004. [Last accessed on 2014 Jan 24]. Available from: http://www.cdsco.nic.in/html/GCP1.html.

                                                                                           

     

                                                                                    Written by: V.Suneetha  

                                                                              Qualification: B.Pharmacy

                                                                                   Student Id:148/0822