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CDSCO shows tremendous progress in reducing regulatory approval time through its ‘just-in-time’ service

Suja Nair Shirodkar
Thursday, June 18, 2015, 08:00 Hrs  [IST]

In a move to enhance the drug regulatory system in the country, the Central Drugs Standard Control Organisation (CDSCO) has started full swing operation of its ‘just-in-time’ services. This unique service, which basically focuses on providing on the spot regulatory approval for hastening the regulatory approval process for select categories, was initially flagged off few months back as a part of the new government's commitment to bring in transparency and efficient delivery of government services.

The CDSCO has identified and is currently implementing this concept on four key areas that have already started showing progressive results in its performance. Dr G N Singh, Drugs Control General of India (DCGI) informed that as of now they have started granting regulatory clearance for export related licenses from the seaports and airports. Interestingly, for this, the Centre has even started and enabled 24x7 services for the stakeholders at all airports and seaports to ease their challenges and strengthen the exports from India.

Keen to push and boost research and development initiatives in the country, the CDSCO has also ensured full utilization of just-in-time programme to grant fast track licenses of new drugs developed indigenously. It is understood that, when earlier the drug approval process under this category took somewhere between three to six months, ever since the just-in-time programme has been initiated, the approval time has been drastically reduced to almost within a month.

Similarly, another significant area where ‘just-in-time’ service is being utilized is for granting personnel licenses. Explaining about the same, Dr Singh said that this is basically to ensure that individual healthcare needs of the citizens are not hampered due to long regulatory approval process. “Under this category, we have started granting on the spot licenses to individuals who under medical emergencies need to import lifesaving drugs or vaccines to India, that do not have marketing approval here, but have so in other regulated markets. We have introduced this keeping in view with our vision that patient safety and their well-being is most important aspect for ensuring best healthcare practices. It is interesting to note that we have seen a tremendous progress in our over all performance since this service has been launched and thus keeping in view our commitment to enhance the over all performance of the drug regulatory system, we plan to expand its ambit in other categories as well wherever we feel it is feasible to adopt.”

Apart from the aforementioned categories, the CDSCO has also extended this service to expedite the grant of no objection certificate (NOC) for conducting BA-BE studies in India, reducing the approval time to only 15 days. Dr Singh further informed that to ensure and provide better services to stakeholders for the same, the Centre is in the process of delegating powers to its zonal and sub zonal offices as well. This will not only ensure proper and timely delivery of services to the stakeholders but will also reduce their challenges in travelling all the way to Delhi to get the approval for the same as from now on they just need to go to their nearest zonal or sub zonal offices, he added.

 

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