Is pharmacovigilance mandatory in India?
Drugs & Cosmetic Act & Its rules 1945: establishment of Pharmacovigilance cell in the pharmaceutical industry is mandatory. National Health Policy: Pharmacovigilance includes Prescription Audit inclusive of Antibiotic usage, Ministry of Health & Family Welfare, Government of India.
Which approvals are required to conduct clinical trials in India Select all that apply?
As set forth in the 2019-CTRules, the Hdbk-ClinTrial, the G-ICMR, and IND-31, India requires an sponsor (applicant) to obtain clinical trial authorization from the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO), and the investigator to obtain ethics committee ( …
Who regulates clinical trials in India?
The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country.
What is CDSCO in pharmacovigilance?
the central drugs standard control organization (cdsco), being the apex regulatory authority for approval of drugs in india, is committed to safeguard and enhance the Public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.
How many ADR monitoring Centres available in India?
There are one hundred and fifty Adverse Drug Reactions Monitoring Centres (AMCs) across the country are functioning and reporting’s Adverse Drug Reactions to National Coordination centre (NCC), Pharmacovigilance Programme of India (PvPI) at Indian Pharmacopoeia Commission (IPC), Ghaziabad.
In which year India joined WHO ADR Monitoring Program in?
In 1997, India became the member of WHO Programme for International Drug Monitoring managed by the Uppsala Monitoring Centre (UMC), Sweden. At inception, 6 regional centers were set up in Mumbai, New Delhi, Kolkata, Lucknow, Pondicherry, and Chandigarh for ADR monitoring in the country (Gupta, 2010).
Who can report ADR?
All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to NCC or AMCs. The pharmaceutical companies can also send individual case safety reports for their product to NCC.
What should be included in the PSUR?
(i) summary of safety concerns (ii) Benefit evaluation (iii) Benefit risk analysis evaluation (k) conclusion: this section of Psur should provide the details on the safety profile of medicinal product and necessary action taken by the mah in this regards.
What are the PSUR regulatory requirements for ICSRs?
The PSUR must provide separate line listings of ICSRs received from India and from the rest of the world. While most of these PSUR regulatory requirements were already in force, a key change is that the PSUR submission must be made to the PvPI in addition to the regulatory authority.
How often do I need to submit PSUR?
After approval of the drug is granted, for the initial two years, PSURs should be submitted every six months. For the subsequent two years, PSURs have to be submitted yearly. If deemed necessary (with regards to public health) by the central licencing authority, the total duration of submission can be extended.
What is a periodic safety update report (PSUR)?
The main purpose of the PSUR is to identify new or emerging safety information, as a means of determining changes in the benefit-risk profile of the authorised drug. Periodic safety update reports are an effective mode of risk communication to the regulatory authorities and an important indicator for the requirement of risk management strategies.