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India specific study for intensive ADR monitoring on pioglitazone to start soon

Shardul Nautiyal, Mumbai
Monday, October 9, 2017, 08:00 Hrs  [IST]

Aimed at carrying out intensive adverse drug reaction (ADR) monitoring exercise related to drugs of current interest, specific study on pioglitazone which will generate India specific data over a period of two to three years is likely to start at Pharm D institutions in the country.

“The study on pioglitazone which will be done in the institutions across the country will help assess ADRs leading to conditions like bladder cancer. Thirty five Pharm D institutions have been identified to carry out such intensive adverse drug reaction (ADR) monitoring exercise under the Pharmacovigilance Programme of India (PvPI),” informed a senior CDSCO official.

According to the official, “The guidelines for the same have been provided to the institutions which are supposed to follow a specific protocol for prospective studies on drugs like pioglitazone having ADRs. This would enable government to take regulatory decision in an effective manner to combat ADRs.”

The exercise has been primarily initiated keeping in view that data from spontaneous reporting of ADRs have generally been misspelt.

Indian Pharmacopoeia Commission (IPC) had recently come out with a draft protocol and guidelines focused on targeted drugs to generate and report India specific adverse drug reactions. For this, institutions are encouraged and trained to carry out intensive ADR monitoring for data generation as per stipulated guidelines in a focused manner related to specific drugs.

Health ministry has also started training Pharm D institutions to undertake specific projects and 35 institutions have already been trained. These institutions have been identified to carry out such intensive ADR monitoring exercise which will be done through a clearly defined protocol and will generate data as per health ministry stipulated guidelines in terms of reporting specific events.

A system for the prospective studies done by the institutions need to be established to arrive at a scientific data through proper protocol of follow-up, ADR monitoring, reporting and analysis. It is a long drawn process and therefore institutions have been provided guidelines on study protocol of drugs of current interest.

To track ADRs in Indian population, Union health ministry launched PvPI which has outreach all over the country but only a small portion of healthcare professionals have formal training in pharmacovigilance.

Health Ministry also recently launched an advanced version of the android mobile application which empowers all healthcare professionals and consumers for ADR reporting.

The mobile application which has been developed by Ghaziabad based Indian Pharmacopoeia Commission keeping in mind the patients, consumers and healthcare professionals is now available online for stakeholders. Through this application, related images of ADR and lab investigation reports can be attached in a user-friendly manner for clinical assessment and signal detection.  

IPC has also signed an MoU with NABH following which around 600 National Accreditation Board for Hospitals and Healthcare providers (NABH) accredited hospitals have also started reporting ADRs as part of their pharmacovigilance activities mandated by the government. The exercise is an initiative taken by IPC to generate awareness in medical institutions to put in place effective surveillance system for detection of ADRs.


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Vivek Hattangadi Oct 10, 2017 3:02 PM
After several fiascos like cisapride, rofecoxib, cerivastatin and many more, it is a really welcome step to have a system for ADR monitoring, reporting, and analysis.

In the past Phase IV Trials (Post-Marketing Surveillance Studies) have never been done with the right earnest.

ADRs vary from race to race. The Indian Genome Variation (IGV) consortium has recently developed the first large-scale database of genomic diversity in the Indian population that will facilitate disease predisposition, adverse drug reactions on a diverse population.

A really welcome step.
Prajith Pharm D Oct 9, 2017 1:38 PM
How to add my college in this program sripms college of pharmacy ?
pradeep Awasthi Oct 9, 2017 10:26 AM
The inclusion of specific ADR reporting related to different category of drugs which are marketed in India by Indian pharmacopea commission based at Ghaziabad,is the need of hour,looking to the many drugs which are not having supportive datas of clinical efficacy and safety,and drugs which are with drawn overnight because of life threatening adverse reactions.

The recent recommendations from national institute of health for assessing the specific drug adverse reactions related pioglitazone,which is used for the treatment of diabetes,is certainly important for medical practitioners as pioglitazone treatment is shown to have incidences of bladder cancer in some group of patients for which it was banned overnight by DCGI,Therefore in accordance of same pioglitazone will be assessed for specific ADR reports having clinical trials of two to three years,confirming its association with incidence of bladder cancer.
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