Pharmacovigilance

Online Pharmacy in Tamil Nadu soon!

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Despite uncertainty over allowing online sale of medicines by the government and its smooth operations in India on safety issues and opposition from offline traders, a registered association of qualified pharmacists in Kumbhakonam in Tamil Nadu is working out a strategy for an online net-work business for sale of pharmaceutical products.

The online net-work of pharma trade, otherwise branded as e-pharmacy, will be brought under the full control of a registered company, managed by registered pharmacists. What is different from other already established online trade groups, this network through internet is that, from prescription check to delivery (dispensing) of medicines to the patients, the full operation is handled by registered pharmacists only. The service of a courier boy is not accessed here, but the service is rendered by a qualified pharmacist only.

Secondly, the controlling company’s agreement for delivery of medicines is with wholesalers and not with any retail shops. It is the responsibility of the wholesaler agent to entrust the duty with the local retailer to deliver the drug to the patient at his door-step/hand delivery. The wholesaler agent must forward the report of the drug delivered, with brand name, company name, batch number, MRP, discounted rate and expiry date of the drug, to the net working company through their website. The same report will be kept by the retailer, the wholesaler agent and is always ready with the company’s website for any time inspection.

The major advantage of this e-pharmacy, according to sources from the net work group, is that the drug is not sent to the consumer by courier from any unknown/far off places, but from the nearest local pharmacy. So, if any problem arises, it can be solved immediately. But, the retailer does not accept any direct online demand from the consumers, instead he has only the delivery contract with the wholesaler-agent. Online demand is made on the website by the customers and the company will forward the same to the wholesaler-agent in respective areas. The order for the online demand will be served to the retail store by the wholesaler who will be in tie up with the net-work group.

The company aims to provide 27 per cent discount to the consumers, 20 per cent of the retail commission and additional 7 per cent given by the wholesaler agent. Only those wholesalers who are ready to provide 7 per cent discount only will be included in the net-working team. The company, which is registered in the form of a public limited company with share holders from all the states, has developed a customized mobile app for the business and will be operational from the first week of January 2017, said Tamil Venden, managing director of Venden Medicals in Kumbhakonam, who has mooted the idea of the net-work retail pharmacy business to the pharmacist associations in various parts of the country.

The company will reach an agreement with the wholesalers in each place and they will, in turn, reach an agreement with retail shops for this purpose. Network company has no direct link with the retailers, but only with the wholesalers. However, the main condition of the business is that drug should be delivered only on prescription and it must be handled by a registered pharmacist. From the retail shop to the patient, a pharmacist’s presence will be ensured.

“This is a start-up e-pharmacy business by our association, connecting retail shops in the country. We are planning to start it first in major cities in Tamil Nadu and gradually will extend the services to all the districts. Each associated share holder pharmacist association will operate the function in each state, and all over the country the services of the net-working company can be accessed in next six months time”, said Venden who is also the chairman of the Tamil Nadu Pharmacist Awareness Organisation (TN PAO) which will control the network business in Tamil Nadu. TN PAO has 800 registered pharmacists who will help the retail pharmacies in delivering the medicines to the online consumers”, he told Pharmabiz.

Source: 1, 2

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IPC issues guidance manual on herbal monographs & quality booklet for PvPI

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Indian Pharmacopoeia Commission (IPC) released the guidance manual for developing Herbal Monographs and Quality Manual for Pharmacovigilance Programme of India (PvPI). This also includes the phytopharmaceutical drugs.

The guidance was released by ministry of health and family welfare secretary, C K Mishra, during the governing body meeting of IPC at New Delhi last week.

This guidance deals with processes involved in developing quality monographs for botanicals/herbs. In fact IPC has been working for over 10 years to develop objectively assessable quality standards for herbs, processed herbs and herbal drugs with a view to provide monographs to the stakeholders. Now 150 monographs of this area are included in Indian Pharmacopoeia (IP)-2014 and its two Addenda published so far.

The scientists during this process have evolved various standard operating procedures for the monograph development. These monographs included in IP have received wide acceptance globally and some of these now appear in pharmacopoeias of other nations with or without further changes.

The Commission felt the need to share this information to stimulate greater work in this area. There had been criticism that quality monographs on herbs and botanicals that were removed from earlier editions of IP. With the resurgence of use of herbs in healthcare and emerging phytopharmaceuticals as drugs, there was a need to provide quality specifications for them.

Now the IPC is taking the initiative to form a separate working group of scientists for this work at the Commission’s laboratory supported and guided by an eminent expert committee on herbs and herbal product as IP is a regulatory book of standards. The manual compiles the knowledge of the process of developing monographs to help the industry and scientists and other stakeholders working in this area.
 
The manual covers various steps in the monograph development criteria, SOPs for monograph development, botanical reference substance, phytochemical reference substances (marker compounds), extracts, herbal product monographs, photography of the candidate material of the monograph. It also includes a non-exhaustive list of suppliers who can provide marker compounds.

Other organisations like the Ayurvedic Pharmacopoeia Committee, Indian Council of Medical Research have contributed immensely to this area. The manual acknowledges and provides information on these publications.

The Commission views that the publication of this manual should help in speeding up the research to provide quality herbals including phytopharmaceutical drugs in consumer interest covering a larger number of herbs.

The efforts of the secretary-cum-scientific director, IPC, Dr DBA Narayana, chairman of the Herbals Committee of IPC, Dr Jai Prakash, senior principal scientific officer, IPC and the associated team are noteworthy, pointed out the Commission.

The Quality Manual for PvPI aims to ensure systems, standard operating procedures to perform the various activities. It was prepared by National Coordination Centre (NCC) for PvPI and was approved by its Quality Review Panel.

While speaking on the occasion, health secretary Mishra, stressed the need of a such quality manual in ensuring harmonized systems and procedure to perform all the elements of PvPI.

Source: 1

CDSCO & PVPI to come up with Pharmacovigilance Guideline India.

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Central Drugs Standard Control Organisation (CDSCO) and Pharmaco-vigilance Programme of India (PvPI) are jointly framing a set of exhaustive guidelines on par with the existing global guidelines to usher in good pharmacovigilance practices in the country for drug safety.

This comes at a time when the government has mandated the market authorisation holders (MHA) to set up pharmacovigilance (PV) cell in their companies in accordance to the Drugs and Cosmetics Rules, 1945 to collect, process and forward the report to the licensing authority for information on adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective MHA in the country through a gazette notification March 8, 2016.

The guidelines will feature pertinent areas like signal detection for risk-benefit evaluation and risk management programmes. Signal management is not compulsory in the present set of guidelines. Risk benefit of the product can be measured properly through signal detection.

The drug exporting pharmaceutical companies can set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.

A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with Contract Research Organizations (CROs) specializing in pharmacovigilance function.

Typical activities in PV department are ADR case processing and reporting (electronic or hard copy), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programs(RMP), literature monitoring for ADR case reports (including local literature monitoring, EU MLM search), training of company employees on ADR reporting, global compliance monitoring, audits and inspections.

The SOPs are expected to cover all pharmacovigilance functions and should be structured comprehensively detailing the  necessary steps. Since pharmacovigilance involves global operations, clearly written SOPs ensures consistency, compliance, and quality, clear assignment of roles and responsibilities, uniform performance over multiple users to avoid errors of oral communication.

The number of SOPs related to pharmacovigilance may vary from few in number to many, depending upon the length and complexity of the processes involved. SOPs ought to reflect the main requirements of the relevant legislation but should also be adapted to the technical and human infrastructure of the company.

List of SOPs for PV Dept involves procedures for collecting the adverse event reports, validating the adverse reaction reports, evaluating the cases for their seriousness, follow up of cases for missing information, expedited reporting, electronic reporting, periodic reports, signal management and risk benefit assessment and response to request for information from regulatory authorities, Interaction between safety issues and product defects, handling of urgent safety restrictions and safety variations, management and use of databases, training, internal audit of the pharmacovigilance system and archiving.

Sources of collection of adverse event reports are health care professionals, consumers, clinical trials, post marketing surveillance studies, regulatory authorities, literature publications, social media, product quality complaints, medical inquiries, pre-clinical research and business partners.

Source: 1

Govt to conclude national drug resistance survey by next month

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The much awaited national drug resistant survey is likely to conclude by next month. The survey which involved doing genotyping studies from TB strains collected from across the country will offer clinical data on molecular epidemiology of TB in the country.

Currently 5000 samples have been collected from patients across the country to determine sensitivity of 13 anti-TB drugs and 80 per cent drug susceptibility testing (DST) process has been accomplished.

The survey is very significant as in addition to diagnosing TB, there is also a need to test for drug resistance so that the most effective TB treatment can be provided.

The universal drug susceptibility testing (DST) is part of the World Health Organisation’s strategy to end TB by 2035.

Culture is currently the main tool for drug susceptibility testing (DST). However, not only is the length of time it takes is a problem, but it also requires trained personnel and expensive laboratory equipment.

Advanced diagnostic tool like Genexpert has gained further impetus as experts advocate the need for DST to be made available to all patients and then provide individualised treatment with the help of DST. Now there is also a thrust upon designing treatment regimens to offer optimal and shorter dosages for children suffering from TB.

Genexpert test is a molecular test which detects the DNA in TB bacteria. It uses a sputum sample and can give a result in less than 2 hours. It can also detect the genetic mutations associated with resistance to the drug rifampicin. New TB tests are required because of the difficulties associated with the tests that are currently used both to diagnose TB as well as to detect drug resistance.

Traditionally TB has been diagnosed by looking for evidence of TB bacteria either through the use of the chest X-ray, through sputum smear microscopy, or through the culturing of bacteria. Each of these TB tests has their disadvantages, one of the most significant for culture being the time that it takes and for sputum in terms of accuracy.

Currently, a patient is first tested for simple TB that needs six to nine months of treatment. If the patient doesn’t respond to this treatment within three months, he is tested further for drug resistance. If the patient is resistant to two of the normal drug regimens, he is said to suffer from multi-drug resistant (MDR) TB. If the patient is resistant to more than two drugs as well as an antibiotic injection given to MDR-TB patients, he has extensively drug-resistant (XDR) TB.

Drug-resistant TB needs over two years of treatment, with drugs costing more than Rs.2 lakh.

India has the highest tuberculosis burden in the world, accounting for nearly one-fourth of the global incidence. Experts advocate that there was a need to have epidemiological data on TB through a nationwide surveillance as was done in China a few years ago.

As of today 19 million TB patients have been treated and 3.5 million additional lives saved as a part of Revised National Tuberculosis Control Programme (RNTCP).

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Should Online Pharmacies be regulated by DCGI?

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The Indian Internet Pharmacy Association (IIPA) has urged the Drug Controller General of India (DCGI) constituted sub -committee formed under the chairmanship of Maharashtra Food and Drug Administration (FDA) Commissioner Dr Harshdeep Kamble on online pharmacy to help set up a registry of online pharmacies to ensure clarity on the legitimate players and frame interim guidelines.

In most countries, the legitimate players are given specific operating licenses that are shared with consumers to fight the menace of cross border internet pharmacies. IIPA recommends a similar model for India, and also a crackdown on all illegitimate players, online and offline.

Meanwhile, Maharashtra FDA Commissioner has also maintained that online pharmacies can sell only OTC drugs and not prescription drugs until the guidelines are framed.

IIPA is a group of online pharmacies represented by 1mg.com, Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com, SaveOnMedicals and Savemymeds.

IIPA has pinpointed that there are multiple online pharmacies operating from different parts of the world that need to be monitored. This according to them will enable legitimate players to develop their business in this space and bring in the much needed innovation and technology driven transparency in this sector, leveraging best practices from across the world.

According to IIPA, online pharmacy is currently governed by Information Technology Act, 2000 and Drugs and Cosmetics Act, 1940.

The Drug Controller General of India had earlier directed all the state/UT drugs controllers to keep a strict watch on online sale of drugs and take action if there is  violation of the Drugs and Cosmetics Act and Rules there under.

Recommendations from all stakeholders are currently being reviewed by the Sub-Committee constituted by the 48th Drug Consultative Committee under the chairmanship of Maharashtra Food and Drug Administration Commissioner to formulate guidelines on the use of information technology in online pharmacy and authorise its legal validity.

Source: 1, 2

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