Regulatory Affairs

Pharmaceutical Industry is considered to be the research-extensive, dynamic, and the most regulated industry worldwide. No medicinal product for human use can be marketed in a country unless it has been approved/licensed by the respective Regulatory Agency / Ministry of Health.

The Regulatory Affairs function is an essential part of the organization for ensuring global compliance and commercial success. The role of regulatory affairs is to develop and execute a  regulatory strategy to ensure that the collective efforts of the drug development team result in a product that is approvable by global regulators. Diverse requirements across regulated markets and emerging markets, new regulations, and greater scrutiny demands constant updates and actions to maintain the lifecycle management of regulatory dossiers.

Different countries find themselves at different junctures with regard to medical issues facing their vast populations. Regulatory policies are therefore directed mostly at addressing country-specific challenges.

 Policies also vary based on meeting demands and targets of various markets:

Emerging markets

Emerging markets are characterized by inadequate medical infrastructure for Primary, Secondary and Tertiary care. Affordability of medicines and medical coverage to larger sections of the population is also a burning issue in these markets. Hence, providing access to basic medicines at an affordable price is a primary goal of health policy in these markets. The challenges mainly arise from economic compulsions and the regulatory policy to a large extent is dictated by the paucity of funds. Price controls with adherence to supply commitments, compulsory licensing provisions, encouragement of alternate medicine and indigenous production, most often become the fall-back solutions. The availability of the latest cutting edge medicines and equipment is a far cry, simply because they cost more and are generally beyond the reach of the average citizen

Developed markets

While access to medical facilities and therapy is much less of an issue, the problem of ballooning costs is reflected in higher and ever-increasing spending on healthcare. Stretched Government healthcare budgets and mounting Insurance costs in these markets bring into question the sustainability of the programs. Government policy is therefore focused on ways to keep healthcare expenditure in check while also having stringent quality assurance mechanisms in place. Overuse of medication and drug abuse are other areas where policy efforts are directed to curb the malaise. These markets have strict patent regimes, respect for inventions and some form of reward for early genericization of healthcare products.

Regulated markets

These Markets are in transition from the emerging to the developed and therefore have suitable policies that are taken from both sides of the spectrum. The economic and health status of the populations shows improvement marked by increasing longevity and physical wellbeing. Hence, healthcare and products for better health are consumed in progressively greater amounts. Government policies are tuned to incentivize better health. Insurance and other synergistic products are encouraged as is the local manufacture of health products and medications. Supporting policies that encourage the availability of new technologies and drugs are targeted towards improving the healthcare status of the local population in these markets. The Policy progressively demands stiffer and rigorous Quality standards. Our Committee on regulatory policy focuses on de-bottlenecking & encouraging the formulation and adoption of policies that go to secure the future health for all, in line with the Millennium Development Goals (MDG) for health, as detailed by the WHO. It works to develop viable alternative solutions and makes constructive suggestions that accelerate the adoption of measures contributing to the overall health and well-being of its constituents. Overall the CHP advocates the best in class policies and practices as relevant to the maturity of each market, be it an emerging, developed or developing market. It does this by marrying relevance with new and innovative methodologies and problem-solving measures. These are evolved through joint discussions amongst its member base, governments and other stakeholders

Pharmaceuticals

The pharmaceutical industry deals with the discovery, development, manufacturing and marketing of drugs or pharmaceutical drugs (branded / Generics) as well as biologicals and biosimilars for use as medications to be administered to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. For generic drug approvals including biosimilars, pharma companies are required to follow product-specific guidances issued by various regulatory authorities describing the Agency’s requirement and expectations on how to develop therapeutic equivalents to specific reference listed drugs. India is the largest provider of generic drugs globally. Indian pharmaceutical sector supplies over 50 percent of global demand for various vaccines, 40 percent of generic demand in the US, and 25 percent of all medicine in the UK.

Medical Devices

Medical device is an article like instrument, apparatus, implant, contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in the diagnosis of disease, treatment, mitigation or prevention of disease, disorder or correction or modification of a body structure of a human being. Medical devices are classified into different categories depending upon the degree of difficulty in assuring their safety and effectiveness as well as the associated risk, intended use of the device, and indications for use and regulatory controls increases based on the associated risk. As per US FDA, the device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and Class III devices require “Premarket Approval”. Pre-market Approval must include data from all nonclinical studies and clinical studies which is reviewed and evaluated critically for its safety and effectiveness. During the approval process, Regulatory Agency will inspect the manufacturing laboratories and facilities where the device will be made to check for good manufacturing practices.

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