It is a well-known fact that the development of advanced medicines and drugs has been playing a vital role in the healthcare services and deliverythat has made the entire healthcare industry to grow at a rising pace. While the Indian pharmaceutical industry is emerging as one of the fast-growing markets in the global scale, it is also expanding its export market across the world. As a result, there need to be proper regulations for medicines to ensure the quality, safety, and efficacy of the drugs. Even a smallest of the mistake can end up recalling the product, leaving several millions at loss for the company. This is why regulatory affairs in the pharma industry has a crucial role to play in all phases of drug development, drug approval, and marketing, in compliance with the norms, regulations, and guidelines.
The Indianpharmaceutical industry is witnessing a steady growth in the global pharmaceutical scene, and as a result of which, is positively affecting the growth of the Indian economy.It has been reported that India’s pharmaceutical sector would touch a whopping US$ 45 billion by 2020 and would become the sixth largest market in the world. The boom of India’s pharmaceutical market experienced in the recent days can be attributed to the rise of pharmaceutical outsourcing and investments by MNCs. The organized and structured Indian pharmaceutical industry is attracting foreign companies for its feasibility of increasing operations in the Indian market. To cope with the growing sector, it has become a necessity for the regulatory affairs to maintain a well-tuned drug regulatory system and regulatory legislation.
Regulation and Regulatory Affairs:
India is home to about 10,500 manufacturing units and over 3,000 pharma companies, and exports all forms of pharmaceuticals from APIs to formulations, both in modern medicine and traditional Indian medicines. Everything from drug development and regulation to commercialization is highly regulated in the country. Every drug must undergo rigorous scrutiny and clinical trials before getting the market approval to ensure its quality, safety, and efficacy. In India, these standards are set by regulatory authorities orthe Drug Control Authority (DCA). Regulation impacts all aspects of the pharmaceutical domain, from pharmaceutical companies and independent innovators to regulatory or administrative bodies and patients.
The regulatory department holds a crucial link between drug products, companies, and regulatory authorities in determining the chances of drug development and the product to enter the market. Regulation involves a broad and extensive evaluation of a particular drug to ensure the protection of public health, drug registration, marketing authorization, pharmacovigilance, import, export, and distribution of the product. Regulatory Affairs is a blend of science and management that helps achieve the commercial goal of the drug-development organizations. RA takes care of everything from the development plan tosupervising/reviewing of the submission guidelines in the drug development and authorization process.
The Responsibilities of the Regulatory Affairs Professionals
The department of Regulatory Affairs is established to protect public health, by monitoring and controlling the safety and efficacy of drugs within several domains including pharmaceuticals, veterinary medicines, agrochemicals, cosmetics, medical devices, pesticides, and complementary medicines. The primary role of Regulatory Affairs is to provide strategic and technical advice to the pharmaceutical companies, right from drug development to the successful marketing of the product.
The Regulatory Affairs have the responsibility to keep the companies informed of the current government legislation, guidelines, regulatory intelligence, and customer practices. It also ensures that the company’s drugs and products comply with the existing regulations and makes sure the entire product range is kept up to date with the changing legislative practices. They also inform about the legal and scientific restraints, limitations, and requirements regarding the product and help companies collect, collate, and evaluate scientific information generated by the R & D department.
An essential role of Regulatory Affairsprofessionals also includes formulating regulatory strategies for companies to submit appropriate regulatory documents for both international, domestic,and/or contract projects.For export and import, the RA advises them about the international legislation and guidelines. They help high-level company executives to coordinate, prepare, and review all documents and submissions given to regulatory authorities, ensuring that they are clear, consistent, and complete from the regulatory perspective.
In today’s competitive environment, a proper conduct of the regulatory affairs activities is vital for the company’s success and sustainability of its products. The regulatory affairs in the pharma industry is what provides physicians and other healthcare professionals with a comprehensive and accurate information about the quality, safety, and effectuality of the drug/product.
As the healthcare industry is growing tremendously, it is necessary for the healthcare professionals to be equipped with industry knowledge along with their academic/technical skills and abilities. In that sense, the Indore Institute of Pharmacy (IIP), one of the best PCI approved pharmacy colleges in Indore, Madhya Pradesh, offers quality education that caters to the very needs of the industry and prepares the students accordingly. Established in the year 2004, Indore Institute of Pharmacy ensures a high focus on quality healthcare and pharmaceutical education that enables the aspirants to become dynamic and competent professionals. Ever since inception, the Indore Institute has been creating a strong foundation in the Pharmacy domain, equipping students with comprehensive knowledge and understanding of the Profession of Pharmacy and preparing them for a successful career.