The Central Drugs Standard Control Organisation (CDSCO) recently began its ambitious project of streamlining the Indian drug regulatory system into a more transparent and patient-friendly body by integrating its existing services. With this objective in mind, CDSCO has drafted some key strategic points that is expected to be adopted in the coming years by the regulatory body to achieve its goal of protecting and promoting public health across the country.

The CDSCO has already started adopting all the requisite steps so as to fulfil all the requirements as recommended by the planning commission in its reports. One key agenda will be to ensure strict implementation of all the provisions of the Drugs and Cosmetics (D&C) Act 1940 and Rules 1945 uniformly throughout the country. Drug Controller General of India (DCGI) Dr G N Singh informed that CDSCO will be taking all the necessary steps to frame and amend the rules and regulations in such a way that it can be put into use to address all the health related issues of the common man.

“Patient safety and their welfare remains to be our main focus and to fulfil this responsibility, we will do our best to adopt a system that is independent, consistent and impartial in delivering its services. To cultivate a work culture that is both accountable and responsible in its dispositions, efforts are being taken by us to streamline the  present system into a more transparent and reliable organisation that will ensure unhindered access to all the required information to the interested parties,” Dr Singh stressed.

Dr Singh further informed that to address regulatory issues and to ensure the safety and efficacy of all the pharma products that are consumed by patients, CDSCO has decided to set up India country offices in five countries with a view to inspect foreign manufacturing facilities and deal with other requirements simultaneously. Similarly, with a view to ensure effective implementation of the pharmacovigilance programme of India (PvPI), the CDSCO has also prepared a detailed agenda that is expected to be set in motion soon.

CDSCO also plans to set up eight new Central Drugs Testing Laboratories with a capacity to test around 8000 samples per annum by each laboratory along with purchase of 20 mobile drug testing vans to monitor quality of drugs moving in the market. Dr Singh informed that all these patient centric initiatives are taken after understanding the importance of public safety. He further added that soon they will also be taking initiatives to set up a pharma research laboratory to carry out sophisticated analysis of drugs to detect foreign substances in them.

“But most importantly to reinstate our commitment towards public welfare, measures will be taken to organise consumer awareness programs to educate and sensitise consumers, medical care professionals and other stakeholders on various drug safety issues pertaining to self medication, information on banned drugs, promotion of generic drugs etc.,” Dr Singh added.

CDSCO has already begun the process of strengthening its workforce by beginning the recruitment process of selecting competent and qualified professionals to deal with the immense work pressure it is currently facing due to shortage of skilled workforce. To address this issue, CDSCO has created an additional 1195 new posts with a view to fulfil the lacunae that is prevalent in the system today. Dr Singh informed that initiatives are also being taken to adopt a strong e-governance programme that will help in establishing CDSCO as one of the strongest regulatory bodies at par with other international counterparts in the coming years.