PV (or pharmacovigilance) era is stuttering to a start and is looking to stay forever in India. As per WHO, PV (pharmacovigilance or drug safety) is 'the science and activities relating to the detection, assessment, understanding and prevention (DAUP) of adverse effects or any other drug-related problem'.
The above interesting image from here.
So here is my viral post on whatsapp:
So here is my viral post on whatsapp:
IMPORTANT PHARMA NUGGET
REGARDING PHARMACOVIGILANCE (drug safety) in India (13.10.17, Sunil S Chiplunkar)
Union Health Ministry has issued pharmacovigilance (PV) guidelines to be implemented by MARKETING AUTHORISATION HOLDERS (MAHs).
The guidelines are issued in Oct 2017 and Govt of India has given 6 months time for its implementation by the MAHs.
Govt of India has released the PV guidelines in form of a pdf document for Marketing Authorisation Holders (MAHs) (Manufacturer and/or importer of drug) of Pharmaceutical Products of India:
Union Health Ministry has issued pharmacovigilance (PV) guidelines to be implemented by MARKETING AUTHORISATION HOLDERS (MAHs).
The guidelines are issued in Oct 2017 and Govt of India has given 6 months time for its implementation by the MAHs.
Govt of India has released the PV guidelines in form of a pdf document for Marketing Authorisation Holders (MAHs) (Manufacturer and/or importer of drug) of Pharmaceutical Products of India:
The guidelines are
issued in Oct 2017 and Govt of India has given 6 months time for its
implementation by the MAHs.
Govt of India has released the PV guidelines in form of a pdf document for Marketing Authorisation Holders (MAHs) (Manufacturer and/or importer of drug) of Pharmaceutical Products in India.
Govt of India has released the PV guidelines in form of a pdf document for Marketing Authorisation Holders (MAHs) (Manufacturer and/or importer of drug) of Pharmaceutical Products in India.
ipc.nic.in/writereaddata/mainlinkFile/File740.pdf
This is also called Draft Version 1.0
MAHs should now have a pharmacovigilance cell or department to fulfil the legal tasks related to:
- ADRs (Adverse Drug Reactions) reporting,
- PSUR (Periodic Safety Update Report) updates
- ICSR (Individual Case Study Report) timelines and checklist
- PBRER (Periodic Benefit Risk Evaluation Report)
- PADER (Periodic Adverse Drug Experience Report)
- AE (Adverse Event) reporting
- Product Quality Complaints Management
- Medical Inquiries Management
- Signal Detection for Risk-Benefit Evaluation
- Risk Management Programmes (RMPs)
- Literature Monitoring for ADR case reports
-Training employees for ADR reporting
- Global compliance monitoring, audits and inspections
- Post marketing surveillance.
The pharma company is expected to meet the PV legal requirements thru' complete in-house department or have arrangement with PV specialist CROs (CRO = Contract Research Organization) or mix of two with clear demarcations in responsibilities.
Each pharma company shall have a PvMF (Pharmacovigilance Master File) located in India, which shall document the PV system for all the marketed products.
Now as per Schedule Y of the Drugs and Cosmetics Act, 1945 each pharma company ie., MAH shall appoint a trained PvOI (Pharmacovigilance Officer-In-Charge) who will be responsible for collection and processing of AEs/ADRs following administration of drugs...the PvOI shall be a medical officer or pharmacist trained in collection and analysis of ADR reports.
Currently scope of PV system as per the pdf document are for:
a) New drugs, subsequent drugs approved after 4 years
b) Biologics
c) Radiopharmaceuticals
d) Phytopharmaceutical products
(Veterinary products and Medical Devices are excluded).
PV structure should be clearly defined...the departmental responsibilities and CRO responsibilities should be clearly demarcated in case of PV CRO arrangement.
The pdf also gives details on PV activity required for pediatric and geriatric usage of products.
PV concept is now a legal requirement and the UCPMP (Uniform Code of Pharmaceutical Marketing Practices) is also on the anvil of becoming a law...both these will have a mega impact on pharma marketing activities (PCD or propaganda and distribution companies and small pharma marketers/manufacturers will feel the impact significantly).
This is also called Draft Version 1.0
MAHs should now have a pharmacovigilance cell or department to fulfil the legal tasks related to:
- ADRs (Adverse Drug Reactions) reporting,
- PSUR (Periodic Safety Update Report) updates
- ICSR (Individual Case Study Report) timelines and checklist
- PBRER (Periodic Benefit Risk Evaluation Report)
- PADER (Periodic Adverse Drug Experience Report)
- AE (Adverse Event) reporting
- Product Quality Complaints Management
- Medical Inquiries Management
- Signal Detection for Risk-Benefit Evaluation
- Risk Management Programmes (RMPs)
- Literature Monitoring for ADR case reports
-Training employees for ADR reporting
- Global compliance monitoring, audits and inspections
- Post marketing surveillance.
The pharma company is expected to meet the PV legal requirements thru' complete in-house department or have arrangement with PV specialist CROs (CRO = Contract Research Organization) or mix of two with clear demarcations in responsibilities.
Each pharma company shall have a PvMF (Pharmacovigilance Master File) located in India, which shall document the PV system for all the marketed products.
Now as per Schedule Y of the Drugs and Cosmetics Act, 1945 each pharma company ie., MAH shall appoint a trained PvOI (Pharmacovigilance Officer-In-Charge) who will be responsible for collection and processing of AEs/ADRs following administration of drugs...the PvOI shall be a medical officer or pharmacist trained in collection and analysis of ADR reports.
Currently scope of PV system as per the pdf document are for:
a) New drugs, subsequent drugs approved after 4 years
b) Biologics
c) Radiopharmaceuticals
d) Phytopharmaceutical products
(Veterinary products and Medical Devices are excluded).
PV structure should be clearly defined...the departmental responsibilities and CRO responsibilities should be clearly demarcated in case of PV CRO arrangement.
The pdf also gives details on PV activity required for pediatric and geriatric usage of products.
PV concept is now a legal requirement and the UCPMP (Uniform Code of Pharmaceutical Marketing Practices) is also on the anvil of becoming a law...both these will have a mega impact on pharma marketing activities (PCD or propaganda and distribution companies and small pharma marketers/manufacturers will feel the impact significantly).
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