Action Steps for Designing India's Drug Regulatory System

Significant changes in the regulatory system are needed to keep abreast with changing trends in the healthcare sector and medical technology industry.

“Medicines fall under two separate legal and regulatory systems: the intellectual property system and the drug regulatory system. These systems have different objectives, are administered separately and function independently. Efforts to integrate these two systems via data exclusivity, “linkage” or other means are likely to have negative implications for access to medicines. Thus, (developing) countries would be well advised to keep these systems separate, and to reject any and all efforts to make connections between them.”

Current structure of Regulation not only restricts global firms entering the market but also curb the opportunities for India in Global market. Before proceeding further with the impact and benefits of Central Drug Authority, CDA lets discuss the scenario and status of Drug Regulatory and Pharmaceutical Industry in India and globally.

Status of Drug Regulatory in India

DRA not being an autonomous body vary immensely in their rules and law making in state and Center. The overall objective to ensure that medicinal products quality, Safety and efficacy remains the same but implementing the policy and measures taken tends to differ a lot in the states.
Whereas the manufacturing / sale and quality monitoring of drugs in the country is looked after by state govt respectively, on the other hand the making of legislation, laying down standards, monitoring imports and exports and Clearance of New drugs comes under the scrutiny of Central government.
Besides this there stands some responsibilities that are performed by both State and Center in collaboration jointly. The duties to be performed jointly are mainly approval of license for the manufacture of the following drugs:

• Vaccine & Sera
• Blood bank & Blood Products
• r- DNA
• Large Volume Parenternals
• Medical Devices.
• WHO-GMP approvals

The amalgamated responsibilities held differently have left the global companies between major haves and haves not. Juxtaposition of Central and state government distinct statutory functions under the act in India , other countries such as USA, Canada, China, South Africa, Malaysia, Australia, Thailand holds Centralized Drug Regulatory Authority.’

In the recent past, India has seen significant growth in the healthcare sector with international expansion strategies through mergers and acquisitions, bringing in increasing investment in core R&D activities. The global pharma and biotech industry has been looking at opportunities of cost effective drug development and India has emerged as a favorable location for drug development. In addition, India-based drug companies have increased their capacity to develop and launch new drugs through their own research efforts. This has heightened the importance of developing adequate internal standards to conduct their operations to be able to compete with the globalization demands.
With rising health care costs, patients, doctors, and health care purchasers, all demand more value from the medical treatments they use. With concerns about health care affordability, it is important to ensure that new medical therapies are effective and provide accurate and current information about using them. More treatments are in development than ever before and finding better ways to demonstrate their effectiveness for particular kinds of patients is essential for making sure that people get the most value from their health care spending. Last few years have also seen an increase in drug safety concerns with some high profile drug withdrawals. This has led to formation of more stringent parameters for safety evaluation of products and therapies by various stakeholders more importantly by the regulatory authorities.
Drug development has also witnessed a significant change through new technologies such as genomics, proteomics, bioinformatics systems, and new imaging technologies. These new technologies have the potential to provide tools to detect safety problems early, identify patients likely to respond to therapy, and lead to new clinical endpoints. New medical technologies, including bioengineered tissues, cellular and gene therapies, nanotechnology applications, novel biomaterials, and individualized drug therapies are being applied to get better therapeutic outcomes.
Regulatory scenario
While there have been advancements in technology, regulations have been trying to keep pace with these changes. Internationally, regulatory agencies have responded to such developments relatively faster than local Indian regulations which are still evolving.
It is understandable that regulations have to be implemented with due consideration to local priorities and capacities yet we in India have been lagging behind probably due to our existing legislative and political system.
The government through several programmes, policies and initiatives has been actively promoting scientific technologies but there has been a relative neglect or a mismatch of the rapidity of technology development versus the development of regulatory aspects, be it relating to health, safety, ethical or environmental dimensions. While various regulatory laws and guidelines have been developed especially in the last few years, there have been inherent challenges with these in terms of interpretation, consistency and enforcement. The issues of manpower capacity at the Central Drugs Standard Control Organization (CDSCO) have been there for years though some of it is being addressed. The regulatory authority will have to be equipped with well trained manpower to address the worries associated with application of emerging technologies associated with drug development.
The national pharmacovigilance system was put into place by the government in 2005. Most countries have such systems since it serves as an important tool to collect data relating to the risk profile of the drug generated under real conditions. The importance of post-marketing surveillance by the regulatory authorities has also been reiterated by a number of high-level committees. Under the current regime, indirect supervision has been mandated through information reporting requirements by the R&D institutions and pharma companies. The task ahead for us is the enforcement of this system across the nation.
There is an urgent need to set up a drug regulatory authority that will oversee all aspects of drug regulations. The concept of one window clearance has to be put in place for anything that is related to healthcare solutions- pharmaceuticals, biotech, foods, diagnostics, devices etc. Significant changes in the regulatory system are needed to keep abreast with the changing trends in the industry. Some of these include—
• Strengthening the authority with trained scientific and medical reviewers for various aspects of research be it ethical, scientific, safety and environmental and also help build a helpful regulating body.
• Building and maintaining a robust pharmacovigilance system and making pharmacovigilance reporting mandatory.
• Coming out with guidelines on fast tracking approvals of drugs or therapies for unmet medical needs (orphan drugs). Considering flexibility in effectiveness criteria (eg partial responses versus survival rates for anti-cancers)
• Developing guidelines on confidentiality, patient privacy and data protection and having well defined ones for research on alternative medicine—AYUSH
• Strengthening and defining regulations for medical devices and other interventional medical or diagnostic procedures involving healthcare.
With globalisation it is important to consider various regulatory developments taking place worldwide and modify the Drugs and Cosmetics Act and rules accordingly. As we continue to change this paradigm of regulations, we have to remember that all the stakeholders have to be participative and contributory to this initiative. All the stakeholders—industry, academia and the regulators can then only realise the real benefits of technological advancements of healthcare.
Future
Any drug regulatory body is an important participant in advancing the development of science, and hence has an important role to play. As an example the US Food and Drug Adminsitration's (FDAs) standards are often used to guide development program-mes, and a standard-setting process is informed by the best science, with the goal of promoting efficient develop-ment of safe and effective new medical treatments.
For India to be a leader in the development of newer technologies and new therapies, the CDSCO or to be formed National Drug Authority (NDA) will help identify the challenges to development, and will work with the larger scientific community on developing solutions. As promoter and protector of public health, the CDSCO/NDA is responsible for ensuring that safe and effective medical innovations are available to patients. This will be accomplished by using available scientific knowledge to set product standards. Ongoing reviews of emerging data on safety, efficacy, and product quality will be conducted by the scientists at the CDSCO/NDA during clinical testing of therapies.
In case of problems, CDSCO/NDA scientists will address them by bringing them to the attention of the scientific community, or by conducting or collaborating on relevant research. The CDSCO/NDA will be issuing guidance documents that will be publicly available summarising best practices in a development area. These guidance documents will be based on the best practices, successes, failures and the drawbacks during clinical trials that the reviewers will observe during the review process. These documents will share the CDSCO's insights into specific issues or topics and also help in ensuring that the current standards of safety and effectiveness are updated. The CDSCO/NDA will help to resolve the product developmental problems identified during the review process by bringing together the stakeholders to identify and address the most significant problems in order to deliver better and affordable healthcare solutions to our patients. All of the above look like a wish list for Indian regulations but in true honesty, these are the important ingredients of any modern healthcare regulatory agency that a nation like India anyway deserves. It is just a question of time and conviction. Through scientific research focused on these challenges, we can improve the process for getting new and better treatments to patients. Directing research not only to new medical breakthroughs, but also for developing new treatments, is an essential step in providing patients with more timely, affordable, and predictable access to new therapies.
The DCG(I) will be involved in setting standards for development of new medical products; we must take proactive steps to use the best science to guide the development process and ensure that development standards are rigorous, efficient, and achieve maximum public health benefit.