Indian and global regulatory systems

Pharmexcil DG stresses on harmonisation of Indian and global regulatory systems to increase efficiency and reduce cost on inspections

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Pharmexcil export of drugs
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Stressing that there is a need to bring drastic changes in the Indian regulatory system by regulatory convergence and greater harmonisation to align with changing regulatory global environments, Uday Bhaskar, director general of Pharmexcil observed that as most of the regulatory agencies across the world are working towards convergence either at bilateral level or at regional level, it is also time that the Indian regulatory system should also have regulatory convergence to harmonise with rules across various nations so that it would help the Indian firms not only comply with the domestic regulations but at the same time adhere to international regulations.

Citing recent example of US FDA which had signed a Mutual Recognition Agreement with EU with respect to GMP inspections and batch certification recognition, the DG said that such regulatory harmonisation could increase efficiencies and reduce costs, avoiding the duplication of effort when regulatory authorities perform overlapping reviews and inspections of clinical or manufacturing sites for similar purposes. “Greater harmonization could enhance R&D, as discordant rules and regulatory approaches add significantly to the cost, complexity, and time needed to bring therapies to patients,” observed the DG.

He said that major objective of regulatory system and regulators is to ensure availability of standard, safe and efficacious medicines at affordable prices. Adding further he also stressed on rationale use of medicines which is of vital importance in ensuring proper healthcare delivery. In this regard, properly drafted and dynamic regulations and robust regulatory mechanism play vital role in ensuring the quality, safety & efficacy of medicines consumed by the patients.

Expressing his satisfaction that over the years the Indian regulators and the regulatory system in the country have been on the path of evolution and continuously keeping pace with the advancing technologies and giving a push for the growth of pharmaceutical industry in the country, which in turn have greatly served the objective of benefiting the healthcare of the poor and needy patients.

He also observed that globalisation has fundamentally altered the economic and innovation landscapes and in the current free market, it is very much essential that the medicines moving across the borders are to be complied with the regulations of the originating country as well as that of the importing country.

In this context, the DG said that new strategic approach with regulatory convergence, greater harmonization and alignment of regulatory rules across nations has gained its significance and it would certainly benefit all stakeholders.


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The DG informed that with changing global regulatory scenario, the Indian government is also moving in that direction and has made several amendments to the Drugs and Cosmetics Act viz draft amendments of schedule M (Good Manufacturing Practices), New Drug & Clinical Trial Rules, Pharmacovigilance System Inspection Guidelines, Medical Devices Rules etc to make Indian drug regulations on par with international guidelines.

As part of this, the DG said added that Pharmexcil along with CDSCO with the support of Ministry of commerce are also working to strengthen partnership of Indian Regulators with Regulatory Authorities of various countries across the globe to establish Regulatory convergence and harmonisation for a greater market access to affordable quality medicines.

To this effect, Pharmexcil & CDSCO had also organised International Regulators Meet in August 2019 with the regulators form about twenty five countries. During the deliberations most of the regulators expressed their willingness to work closely with CDSCO in addressing the issues of mutual interest by signing MoU/Mutual Agreements similar to that of EU and USA, to facilitate recognition of product approvals, inspection & audits and reduction in timelines & cost etc.

In the process of achieving easy market access for drugs with Indian Pharmacopeia standards, Afghanistan is the first country which has recognised Indian Pharmacopeia as the book of standards, and it paves way for similar recognition by other countries.

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