Revamping Drug Inspection and Monitoring Mechanism: Institutional Gap between Central Drugs Standard Control Organisation and the States of India is Worrisome | Gautam Sen

Within the purview of the Drugs and Cosmetics Act, a Central statute, the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services attached to the Ministry of Health & Family Welfare of the Government of India, is responsible for approval of drugs, conduct of their clinical trials, specifying their standards, and ensuring control over the quality of imported drugs. The CDSCO is also mandated to maintain standards pertaining to drugs, cosmetics and medical instruments introduced in the Indian market for public use. Furthermore, the CDSCO is also responsible for coordination of the activities of the state drug control organizations and providing expert advice with a view to ensuring uniformity in the enforcement of the Drugs and Cosmetics Act.

In its drug alert for August 2024, the CDSCO had listed that, samples of more than 50 drugs, including some commonly used drugs like Paracetamol, Pan-D, Calcium, Vitamin D3 supplements and anti-diabetes pills, as not of standard quality. Drug manufacturers protested against such categorization, declaring that the drugs were not spurious but fit for patient intake. However, the fact of the matter remains that these common user drugs from those sampled by CDSCO, were below standard, implying thereby that, the outcome expected on intake may not be achieved. However, the drugs categorized as above, were those manufactured by some companies only and not of all manufacturers.

The situation revealed as above, requires the adoption of remedial measures institutionally. First and foremost, the reach of the CDSCO has to be widened within the country, involving the strengthening of the six zonal branches of the parent body at Chattisgarh, Goa, Daman & Diu, Silvassa, Madhya Pradesh and Maharastra, four sub-zonal offices, 13 port offices and seven laboratories, and their expert manpower complement and professional expertise enhanced. Moreover, the scope of inspection of samples has to necessarily include checking the raw materials used, the mid-course processes of manufacture, and the end product on a random sampling basis, rigorously and in a confidence-inducing manner by in-house facilities of CDSCO or by properly accredited labs which are not beholden to major or multi-national drug manufacturers in any financial or institutional manner. In the existing circumstances, it may be appropriate to leave nothing to self-certification by the drug manufacturers. Furthermore, the samples of those manufacturers whose earlier samples had failed quality checks within a specific period of the latest sample offered for inspection, should be subjected to specially rigorous inspection.

There is however, an institutional gap in the drug certification process in the country as a whole. The drug inspection and certification process is not suitably networked in India. This is because each state in India has their own mechanism for dealing with the subject of issuing licenses and certification of the drugs manufactured in the respective state. There is no linkage or information flow between the different states and their licensing, certification and inspection mechanism on either post-facto basis or real time basis with the CDSCO and the its regional outfits. Thus, a drug cleared by a state`s licensing and inspection apparatus may fail a CDSCO`s inspection subsequently and occurrences vice versa also, cannot be ruled out. Without an appropriate networking of the Central government`s drug inspection machinery, particularly its regional units, with their counterparts in the states, below-standard drugs and even spurious drugs may flow into the national market at the peril to the nation`s health ie. of its citizens. This is a possibility which can be effectively prevented with the present nation`s technological capability. The Economic Survey 23-2024 generated by Government of India incidentally mentions that ``the Central government is committed to ensuring sound health and well-being of all ages through a preventive and promotive healthcare orientation in all developmental policies and universal access to good quality healthcare services``. A suitable computerized oversight mechanism on drug manufacture, inspection and supply would only serve this purpose.

Apart from the issue of networking and need for real time information flows among the states` drug controlling apparatus and CDSCO, there is a requirement of developing ethics and systems in the drug manufacturing and approval process. The yardsticks should be similar for the country as a whole. Public Health being a state subject under the Indian Constitution, implies that it may be difficult to impose the standards from the top ie. through the Union government and the CDSCO, and a consensual approach between the Union government and the state governments is warranted. However, endowing the `right to health` as a fundamental right of the citizens, will enable adoption of legislation and regulations at the Union level to institutionalize a national framework, which ensures similarity in standards and prevents the marketing of drugs in respect of which there are doubts on the manufacturing process and have not attained the threshold quality at the final product level.

There are however, some positive developments. The CDSCO has recently stepped up efforts for auditing facilities connected with the pharma ecosystem. The Central drugs regulator ie. the CDSCO, is reported to be working on a material-to-patient infrastructure under the same roof. A digital drug regulatory system is planned, which will be an overarching portal for all activities related to pharmaceutical regulations. The present SUGAM on-line e-governance portal which encapsulates all activities of CDSCO and intended to build an in-depth regulatory framework for registration processes of the CDDSCO, will be expanded and the state drug controllers will be integrated eventually with this system, followed by other agencies like the Customs and GST departments, the Indian Council of Medical Research, the Indian Pharmacopoeia Commission. The supply chain track-and-trace mechanism will also be integrated, to track raw material sources, and finally the retailers will also be connected to ascertain the real sales status in the market which will enable a total view of the drug availability, their quality and disposal to be obtained both at the CDSCO level and with the state drug controllers at any point of time.

If we can move to a regime similar to the European Regulatory System for Medicines of the European Union operated by the European Medicines Agency (EMA), wherein a pool of more than 4000 experts drawn across Europe evaluate the medicines, issue European Public Assessment Report for every human or veterinary medicine granted or refused marketing authorization following an assessment by the EMA in a time-bound and transparent manner, under the administrative control of the European Commission (the political executive of the EU), we would have reached a desirable threshold in the realm of our public health.

(Author: Gautam Sen is a retired senior Civil Service officer of Government of India with experience of working on development programme)