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Strict prosecution law will fix the drug regulatory system

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Bejon Kumar Misra, Founder Director, Patient Safety and Access Initiative of India Foundation (PSAIIF) in a tete-e-tete with Prathiba Raju, says that the government should bring in new, updated, patient centric Drugs Control Act without any delay

India is the third largest drug producer in volume and 12th largest in value globally, yet we lack a pharmacovigilance system in our country. What are the reasons behind this?

Bejon Kumar Misra

We have a Pharmacovigilance Programme of India (PvPI), which is yet to be fully utilised as either patients nor medical practitioners are aware about its existence. Many in India are not aware about the toll free helpline telephone number of PvPI, which is 1800-180-3024. You should call at this number and report any kind of adverse drug reactions (ADRs) when you feel that medicines administered didn’t provide the expected outcomes. Every medical practitioner should use this number. We must also encourage patients to use the toll free number.

Is the Drug Controller General (India) (DCGI) struggling to ensure the quality of drugs in the market?

DCG(I) is definitely struggling as it lacks infrastructure and the desired cooperation from state drug controllers. We have extremely poor reporting systems on drug testing and its outcomes. Though there is data, we don’t know how credible it is and whether they have been conducted in a statistically scientific manner. We must introduce third party audits and encourage patient organisations to get engaged with the state drug controllers. We are trying our best to improve the system based on the Mashalkar Committee Report and other Parliamentary Committee reports.

What steps should the government take to upgrade the regulatory set-up?

The government should have a modern, updated and stringent law in place of the existing Drugs and Cosmetics Act 1940. The British Raj has left but we are still continuing with the Inspector Raj. We should now move forward and make patient safety and accessibility to quality healthcare as the main pillars to the proposed law and ensure proper coordination between the Central and the state governments. We should have established testing facilities with National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation in every district of the country and make the process transparent and accountable to the patients. Good manufacturing and distribution practices, equivalent to if not more than the global best standards should be followed.

How has online pharmacies transformed the average Indian healthcare consumer?

Online pharmacies have brought choice to patients and dismantled the cartels which existed in our country in the garb of associations of chemists and druggists. Now, we have a fair competition and the manufacturers of medicines in our country can have options to sell their products to the consumers at a competitive price. The only challenge is that online pharmacies are not regulated in the manner desired and states doesn’t allow them to function for the interest of the consumers. The Sub Committee constituted for the purpose of recommending the governments on how to regulate online pharmacies, is a right step and hopefully by the end of this month, the committee will be able to submit  its recommendations.

What would be a clear-cut operating model for online pharmacies which is in line with the concerns of the chemists, while providing benefits to customers?

A level playing field between online pharmacies and regular physical stores to ensure safety and quality to the consumers is a must. Moreover, proper documentation of medicines are necessary so that they are not prescribed irrationally and the government should introduce a robust track and trace mechanism.

The European Union has issued a common logo for legally operating online pharmacies/ retailers in its member states as one of the measures to fight against certain illegal pharmacies. Will similar measure work in India?

Of course it is viable in India. We have also proposed a similar accreditation system like the EU, the US and the UK. In fact, India is known globally for its expertise in IT and it is high time that we create a repository of information on the brands, volume produced and how much has been sold.

What changes would you like to see in the next five or ten years in the pharma sector?

We need institutionalised testing facilities in all districts of our country and prompt action needs to be taken to recall medicines which are found to be spurious or Not of Standard Quality (NSQ). A modern law, which punishes the culprits who play with the health and safety of the patients and a strong pharmacovigilance programme in India with a efficient tracing and tracking mechanism is a must. Slowly reducing the number of brands made available in India and we should focus on making generic names mandatory for medical practitioners to write along with the equivalent name of the branded medicines. Bringing fair competition and a strong regulatory mechanism will ensure all essential medicines are made accessible in adequate quantity and not bring price control as it breeds unfair business practices and denies the patients from accessing quality and safe medicines.

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