At the peak of the pandemic when the virus was tearing through India, a high-powered committee was set up to recommend changes in the Indian drug regulatory system, which essentially meant restructuring the Central Drugs Standard Control Organisation (or the CDSCO in quickspeak) which is headed by the Drug Controller General of India. A little over a year since, the process has now been set in motion to implement the recommendations made by the committee. Set up in May last year, the committee was headed by Rajesh Bhushan, the current health secretary but back then the OSD (Officer on Special Duty), ministry of health.
Financial Express Online now learns that the recommendations have been accepted by the health ministry and it is in the process of implementing these changes and wherever approvals from the cabinet are required, the health ministry is in the process of submitting the proposals to the cabinet for approval.
Timeframe for changes
In terms of timeframe, wherever there is need for rule amendments, it is likely to take another four to five months and wherever there are elements like creation of new posts, which is also mooted, including that of elevating that of the Drug Controller to that of an additional secretary level as against a rank of joint secretary at the moment, will take another six to eight months while the rest of the features, where there are no financial implications, the changes are being put in place. So, all in all, the new drug regulatory system may be in place in the next eight to nine months if all the recommended changes are carried out.
Seeking to Spur Innovation
What is most crucial is the whole restructuring of the CDSCO. The apparent aim is to speed up the process of approvals, spur innovation and the ease of doing business. How this will pan out needs to be seen but the changes by themselves, many in the industry see as quite pathbreaking. For instance, the CDSCO to be headed by a Medical Products Controller General of India at the level of additional Secretary to the government of India.
Focus Verticals
The restructuring of the CDSCO includes putting in place five verticals within the CDSCO in an apparent bid to provide greater focus and specialisation. These being:
1, For New Drugs, cosmetics and clinical trials
2, Biologicals
3, AYUSH
4, Medical Devices
5, Legal, Enforcement and Investigations.
The CDSCO is also to be renamed. Though the new name is not clear as yet, the impression seems to apparently seek a more all-encompassing title like an “administration” rather than say a more intimidating sounding ‘control’ or ‘controller.’ But this will have to wait. Equally crucial, if not more important, the CDSCO is to be given status of an “attached office” of the ministry of health and family welfare. At the moment the CDSCO is a subordinate office to the DGHS or the Directorate General of Health Services in the ministry of health and family welfare. By an “attached office,” it is meant to convey that the CDSCO will henceforth be directly under the administrative control of the health ministry. That apart, a Centre of Excellence for Regulatory Science and Research is also to be established.
What is expected to help fast-track the approval mechanism, which apparently, was one of the key aims behind the changes, is the complete review and redesign of its e-governance model and putting in place a single unified interactive portal which will mean revamping its current SUGAM portal, leverage Artificial Intelligence and Data Analytics. The functioning of Subject Expert Committees, which as was seen in the recent process of vaccine approvals, has a critical role to play, through IT enabled system is also being worked upon.
The restructuring of the permission and mechanism in drug discovery/ preclinical stage is also to be in place with the sub-committee for RCGM (Review Committee on Genetic Manipulation), sub-Committee on GEAC (Genetic Engineering Approval Committee) and the CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals) – all with timeline for disposal of applications, failing which deemed to have been approved.
With an aim to promote drug discovery and innovation, there is a plan to streamline the regulatory process and thereby strengthen the ecosystem for innovation, look at the regulation of Clinical Research Organizations, ensure the confidentiality of documents submitted to CDSCO along with applications and to provide regulatory guidance through single point of contact for development of NCE (New Chemical Entity) / NBE (New Biological Entity).
This is to be aided by a streamlining or simplification of activities. These could be around manufacture of commercial batches of new drugs under clinical development, provisions for manufacturing of test batches, parallel submission of applications for new drugs approvals and import registration; development, testing and lot release of vaccines. The focus is also to have in place a well-defined regulatory provision for Vaccine, rDNA derived product and Stem Cell, Cell based products, Gene therapeutic product and the rest. The move is also to apparently promote high quality AYUSH drugs and have in place a separate regulation for Over-the-Counter drugs.
Global standards
Many in the industry welcome the stated intent to adopt global standards for becoming members of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and PIC (Geneva-based Pharmaceutical Inspection Convention). In fact, it is a space where India has some distance to cover compared to China, which around 2017 had its Food and Drug Administration join the ICH and even PIC as a member. Many in the industry see this as a factor that forced the Chinese drug regulator to become more stringent.
What perhaps stands out in the proposed changes is what is being called “regulatory impact analysis” and the idea here is before makes amendments in the rules or before drafting new rules, conduct an impact analysis to access the extent to which the changes are going to make a difference to manufacturers and to the public at large. To what extent, this has been done for the proposed changes is not yet clear though attempts seems to be look at changes from all dimensions including the extent of financial burden on the manufacturer to comply with any proposed amendment to rules. But the apparent assessment within the system seems to be that the proposed changes should spur innovation in the country as many regulatory hurdles are to be removed and there is to be greater use of IT and therefore more transparency and ease of doing business and especially the aspect of setting timeline for disposal of applications, failing which they would be deemed to have been approved, are being seen as moves that will make a material difference. Those within the industry do seem to see time-bound approvals as a crucial area needing improvement. Nonetheless, those within the industry would still want to wait and watch all the changes unfold.
While the Indian drug regulator has been talking for some time now about the its attempts to collaborate with regulators abroad, the focus is reiterated once again as efforts to enhance collaboration, cooperation with other regulatory authorities for ensuring quality of imported drugs.
Within the country, the streamlining of the regulatory process at the state level has also been emphasised in an apparent bid to ensure uniform administration and effective implementation of the provisions of the Act and Rules through e-governance, guidelines and training.
There is also a move now emphasised to put in place a proper mechanism for external audit of the CDSCO and the state licensing authority. The CDSCO is to also have its own state-of-the-art building as the head quarter and the National Drug Regulators Training Academy. Also, the CDSCO officials are to be sent on deputation to state drugs control organizations and vice versa to ensure uniform implementation of various provisions of the Drugs and Cosmetics Act, and rules.
Much of this is also to be backed by a proposed plan to have effective monitoring and supervision of all vigilance activities related to drugs, medical devices and blood safety and a new Act for regulation of Drugs, Cosmetics and Medical Devices.
The pain points that many point out is that there is not much on checking the spurious and sub-standard drugs, the assumption is that the new rules and guidelines coupled with increased use of IT meant to enhance transparency, will all go out to check drug quality.
Beyond money & manpower
What one of the industry leaders, preferring to stay anonymous, says the new changes are a step in the right direction but an entity like a drug regulator needs greater autonomy, financial muscle and much more addition to its manpower. Currently, the annual budget for drug control in India is in the region of around Rs 150 crore for the central drug control and about Rs 520 crore including the Centre and the states (this is as per a report by the Comptroller and Auditor General of India for 2018-19). Compare this with the USFDA (US Food and Drug Administration), what to some is still an aspirational drug regulatory authority despite its flaws: The annual budget for the USFDA was $5.9 billion in FY 2020 with 33 per cent earmarked for regulation of drugs used on humans. While the Indian and the US regulators cannot be strictly compared as the US drug authority operates globally too. But many still see a case for at least a 40 to 50 per cent increase in budget for the Indian regulator and also a substantial jump in the manpower – currently including the drug inspectors to deputy drug controllers in the states, the number is roughly around 2500 and many feel for a country of India’s size, there is arguably a need for a five to 10-fold increase in manpower but then what is more than the number is the manner in which they are all deployed.
While Indian drug regulations have to be streamlined and kept in tune with the best practices globally, the manpower needs to be deployed more for checking drug quality, checking spurious and sub-standard drugs and let the technically skilled add to the regulatory approval capability.
Some of the highlights of the proposed changes:
- Restructuring of the CDSCO and it is to be headed by Medical Products Controller General of India with the rank of an additional secretary.
- Five verticals to be created within the CDSCO – New Drugs, cosmetics and clinical trials; Biologicals; AYUSH; Medical Devices; Legal, Enforcement and Investigations.
- The CDSCO to be renamed.
- The CDSCO to be given status of attached office of the ministry of health and family welfare.
- With an aim at ease of doing business, have a unified interactive portal and revamp the SUGAM portal, use of artificial intelligence and data analytics.
- Functioning of Subject Expert Committees through IT enabled system.
- Restructuring of permission and mechanism in drug discovery/preclinical stage (under a single window system).
- Adoption of Global Standards for becoming members of ICH and PICs.
- Have a system of a regulatory impact analysis before making any rule change or amendment to assess the impact of any measure.
- To streamline the functioning of Port Offices.
- To have in place effective monitoring and supervision of all vigilance activities related to drugs, medical devices, blood safety among others.
- Have a new Act for regulation of drugs, cosmetics and medical Devices.
