Growth of Pharmacovigilance in India

Ø PHARMACOVIGILANCE: As per WHO, it is defined as

The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems

 

Ø History of Pharmaceuticals in India:

Ø  Like in other parts of the world, a large number of distinguished pharmacologists in India began researching adverse drug reactions (ADRs) and attempting to comprehend the notion of pharmacovigilance in the late 1960s, coinciding with the rational use of medication by these scientists. Every available and approved drug was known to be unsafe and to have the potential to cause side effects even at therapeutic doses. A national seminar on pharmacovigilance was organized by the Indian Pharmacological Society (IPS) during the Silver A Jubilee Celebrations program at Maulana Azad Medical College, New Delhi, from October 21–22, 1983, to create awareness about the problem of adverse reactions at normal doses.

Ø  The importance of a pharmacovigilance system began to attract prominence during the 1990s. Although not exclusive to India, major adverse reactions to medications such as Practolol and Thalidomide had worldwide repercussions, emphasizing the significance of an effective ADR monitoring system. The first three-year multi-centric monitoring project of epidemiological profiles and causes for adverse drug responses in India was funded by the ICMR and took place at the Department of Pharmacology at Jawaharlal Medical College in Aligarh It has been reported that adverse reactions occurred in more than 50% of cases due to the usage of antipsychotics (76.47%) and antidepressants (51.14%). The first scientific pharmacovigilance conference was held in January 1997 in Mumbai. In 1997, the WHO signed a contract to establish pharmacovigilance centers in India. As a result, three centers were identified and established. India has also become a part of the international drug monitoring program.

Ø  2004: PvPI (Pharmacovigilance Program of India): The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, Government of India, initiated the Pharmacovigilance Program of India (PvPI) in 2004. The primary objective was to protect the population from harmful ADRs by collecting and analyzing data.

Ø  2009 onwards: PvPI Revamped: In 2009, the PvPI was revamped to improve ADR monitoring. The Indian Pharmacopoeia Commission (IPC) in Ghaziabad was designated as the National Coordination Centre (NCC) for the program. This strengthened the infrastructure for ADR reporting and increased awareness about pharmacovigilance among healthcare professionals.

Ø FROM ADVERSE EVENTS TO PATIENT SAFETY, here is how pharmacovigilance is bridging the gap between patients and healthcare providers.

The national program of pharmacovigilance was launched in 2005 and was renamed the Pharmacovigilance Programme of India (PvPI) on July 14, 2010 at AIIMS, NewDelhi, and

·       As of right now, 179 corporate and teaching hospitals that have received approval from the Medical Council of India are designated as ADRs Monitoring Centers (AMCs) around the nation. For administrative and logistical reasons, the Central Drugs Standard Control Organization (CDSCO) has four zonal offices that oversee these centers. International networking is connected to these AMCs (reporting via software from the WHO-Uppsala Monitoring Centre [UMC], VigiFlow). Via WHO-UMC's (Sweden) software, VigiFlow, these AMCs report ADRs to the NCC. As a result of the PvPI's comprehensive roadmap for a proactive pharmacovigilance system, which raises awareness of the advantages of ADR reporting, the reluctance to report is now changing.

·       ADR MONTORING CENTRE’S IN INDIA, which contributes to 1.7% of total individual case safety reports at the UPPSALA monitoring center's database.

 

 

 

·       As India has huge ethnic and genetic variability with an increased prevalence of diseases day by day, numerous varieties of pharmaceutical drugs are available on the market that have proven adverse effects but continue to be used due to the factor of benefits outweighing the risks. An adverse drug reaction is a causal relationship between the drug and the event. The common types of adverse drug reactions occurring in India are:

·       The introduction of digital platforms for advertising and reporting has shown a significant impact on ensuring the safety of the citizens of India. A filled-out ADR can also be reported by mailing the filled ADR reporting form to pvpi@ipcindia.net or calling the toll-free helpline at 1800-180-3024.

CONCLUSION:

·       We have learned about the development of pharmacovigilance.

·       Pharmacovigilance is important to detect, assess, understand, and prevent the adverse effects of medications.

·       ADR monitoring is essential for the well-being of the nation and the world.

REFERENCES:

 1World Health Organization (WHO) https://www.who.int/

2.https://www.researchgate.net/publication/363377463_History_of_Pharmacovigilance_in_India_1983-2022

3. PvPI: cdsco https://cdsco.gov.in/opencms/opencms/en/PvPI/

4.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576445/ 5.https://globalresearchonline.net/journalcontents/v63-1/12.pdf

6.https://www.ipc.gov.in/images/PvPI_Newsletter_-_Vol._13_Issue_2_2023_Com.pdf

Student Name: Emani.Sai.Sri.Jayanthi

Student ID:203/102023

Qualification: Pharm.D

e-MailIDjayanthi.emani@gmail.com