Pharmaceuticals Industry Needs A New Regulatory Framework | SupportBiz

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Pharmaceuticals Industry Needs A New Regulatory Framework

 
FICCI has been appointed as the nodal agency by the Drugs Controller General (India) for consolidating the guidelines

The role, responsibilities and liabilities of e-commerce marketplace and the product sellers need to be clearly defined. It becomes even more critical to have a framework in place when the intermediary is selling drugs where the safety and health of the consumer is of paramount importance.

This was stated by Dr. G. N. Singh, Drugs Controller General (India) at a FICCI consultative meeting on ‘Pharma Guidelines for Reinforcing Due Diligence for Intermediaries (E-commerce Marketplace)’.

FICCI talks of due diligence by marketplace to ensure consumer safety while selling of drugs online.

FICCI has been appointed as the nodal agency by the Drugs Controller General (India) for consolidating the guidelines and was seeking views of OPPI, All India Chemists and Druggists Association, States Chemists and Druggists Associations, Indian Medical Association, CIPI, BDMA, PHD Chamber of Commerce and Industry and consumer forums, in this regard.

Dr. Singh said that pharmaceuticals industry needs a new regulatory framework to effectively bring e-pharmacy under its ambit. The Drugs and Cosmetics Act does not have any guidelines for e-commerce players in pharma.

Hence, it is essential to create guidelines for e-pharmacy that checks efficaciously the use of technology as safety of patient, quality of drugs and robust supply chain are prerequisites for Drugs Controller General of India. With the advent of technology, e-commerce industry has entered in healthcare space in the form of e-pharmacy. However, there are issues such as complaint being filed against e-commerce player/s for online sale of prescription based drugs.

To resolve these issues, Dr. Singh suggested that it would be beneficial for the regulator to engage with stakeholders in constructive brainstorming deliberations to reach a consensus. He added that the Indian Government was forthcoming in adopting industry’s recommendations and the Drugs Controller General would assist in providing a legal status to implementable suggestions of industry.

Dr. Singh assured that the interest of small retailers will be protected and it would be ensured that e-pharmacy does not disturb the existing supply chain system in place. The aim would be to integrate e-pharmacy in the existing system.

Besides industry, in the consultative meetings, consumers, doctors and pharmacists should be adequately represented to have a holistic view on the issue, which would enable formulation of an innovative policy framework. He added that the Indian regulatory body was also engaging with international regulators in the space to derive a forward looking policy.

Dr. Arbind Prasad, Director General, FICCI, said that FICCI in consultation with stakeholders had prepared a representation for Drugs Controller General titled ‘Suggestive Guidelines for Reinforcing Due Diligence for Intermediaries (E-Commerce Marketplaces)’.

He informed that the document comprehensively discusses the challenges faced by the sector and also proposes recommendations which can be deliberated upon to resolve these issues.