In the past few decades, drug control has become a major concern in India, and as well as in foreign countries, it also has been a subject of scrutiny and controversy in the public sphere and the academics. Not turning down the fact that these new drugs are significantly contributing to human welfare in both ways, by making life-threatening diseases treatable or by trying to improve the lifestyle of patients for non-curable diseases.
However, if there are pros then there will be cons. These things come with an element of risk, as it is associated with troublesome side effects. In this industry, the risk-taking factor is so high that it has become a central organising concept in regulation-making, especially in the pharmaceutical industry. The approach of the drugs and pharmaceuticals industry and its regulation is a recent development, whereas the use of medicines is controlled by society.
New drugs mean new molecular entities which take different forms ranging from reformulated generics to fixed-dose combinations of existing drugs. There are two reasons for the processes and approval of the new generics and FDCs, and those are: the drugs constitute a majority of new drugs and the approval process for new molecular entities.
The drug approval process has been marked by several controversies in India which involve frequent rollbacks, and changes in the guidelines and recommendations. The study to analyse the regulation-making process for approval of new drugs in India through the prism of institutional economics and science and technology studies on regulation-making is done by the institution which emphatically notes that an institution derives its credibility by offering a stable pattern of behaviour to explain and draw relevant policy lessons from such events.
The regulations and pharmaceutical laws are necessary so that the government can establish effective national regulatory authorities so that they can make sure that the manufacture, trade, and use of medicines are managed properly, and if the public has the access to correct data of medicines.
Indian regulatory authorities issued guidelines that say that a BA/BE study is also required if changes are sought in an FDC, which is already in the Indian market. This reveals an interesting communication between science and clinical practice as we use regulatory wisdom to shape the process. Clinical practices related to the use of drugs, used in an FDC can make a case and can release it from trials and BE studies, and same goes with an FDC which is approved and marketed in other countries and profound research declares that the complex relationship the central authority had with its state-level counterparts.
In many situations, it has been noticed that the regulatory authorities in the states have provided licenses for FDCs without sharing the important information with the central authority. The state authority officials have, together with the incomplete regulatory capacity of state regulatory authority, has allegedly aggravated the situation where many irrational combinations have been approved without the approval from the central regulatory body, which is mandatory for all new drugs. A part of the industry and the Courts have questioned the attempt to label these irrational combinations without much concrete evidence of safety hazards, which has made judicial intervention a difficult task.
It is clear that the Indian regulation-making process for new drugs is at an elementary stage, and it looks like it will heavily tie with the regulatory knowledge of other industrialised countries. As we all know, at the moment, there are many exceptions from human-based trials that are granted if the drugs are accessible and marketed in advanced economies. The level of confidence might, at times, be welcomed from the viewpoint of public health and trade which reduces the duplication of human trials, costs, and time of the drug approval.
The obstacles can be put on the generation of new knowledge by the indiscrete dependence on other countries’ regulatory wisdom. The Rajya Sabha Report in 2021 stated the need to delegitimise certain FDCs primarily if not totally, because they were not approved in the counties with advanced regulatory capacity, ignoring the possibility of their therapeutic efficacy, which was finally proved by academic study.
The performance of clinical wisdom has not been given attention in the regulatory processes in India. To delegitimise several FDCs, we find that an attempt has been taken by the regulatory authority to control the clinician’s practice by banning some FDCs on the grounds of their possible misuse and overdose.
To give you an insight into this issue, we drew upon the growing body of scholarship in the range of regulation-making which usually contests the higher prestige of laboratory knowledge. Factually, this view hints at the debate between what works and what ought to work.
Poor downward causation of the rule seems to be another essential aspect of the Indian new drugs approval mechanism. This aspect manifests in the reason for the persistence of the so-called ‘4-year clause’, which was a good response to inadequate and slow-moving technological capacity to standardize test assays for new drugs. However, it has continued to be a ‘black box’ among policymakers. One may find a separation of the regulatory process referring to the new drug approval from the larger institutional settings.
This problem supposedly occurs as a result of regional competitiveness (specific states) and a "nexus" between state regulatory bodies, local industry, and physicians. If the Parliamentary Standing Committee on Health and Family Welfare's report is to be taken seriously, a similar link exists at the national level as well. India is not the only country where states compete for regulatory supremacy. Furthermore, health care in India is the responsibility of various states, greater focus must be paid to developing regulatory capability at the state level.