Importance of regulation in the pharmaceutical industry

Today Regulatory Affairs is a dynamic business unit working with a focus to bring commercially viable labeled products to market in the least amount of time and expense possible. In view of the increasing global competitiveness among pharmaceutical companies, the key to success lies in obtaining timely marketing approval from the Regulatory Affairs of the region where the drug will be sold. Various government agencies are involved in the regulation of drugs within their market. Some of them include:


Patent expiration, tight healthcare budgets, and a tight regulatory climate are major challenges for the pharmaceutical industry. Many companies are in a race to get their new products on the world market and gain market share and increase profits.

In such a scenario, a small delay in gaining access to the market means a large loss in terms of market share and revenue generated. The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators. Therefore, to obtain timely marketing approval, companies can either strengthen their regulatory department or outsource it to a regulatory affairs consulting firm.

Current regulatory scenario

The main legislation governing clinical trials is the Medicines and Cosmetics Act 1940 and the authority of the Directorate is the Comptroller General of Medicines of India (DCGI). Annex Y of the Medicines and Cosmetics Rules of 1945 stipulates the regulations for the importation and manufacture of new medicines for sale and for conducting clinical trials in India. In addition, the Indian Council for Medical Research (ICMR) has published Ethical Guidelines for Biomedical Research on Human Participants and the Central Drug Standards Control Organization has formulated Good Clinical Practice Guidelines (GCP Guidelines) in accordance with issued international guidelines. by the World Health Organization and International Harmonization Committee (ICHGCP), which provides operational guidelines for ethical and scientific standards for the design of a clinical trial protocol that includes conduct, registration, safety and reporting procedures. It is mandatory that all organizations conducting a clinical trial in India strictly adhere to these guidelines.

There is no denying the fact that clinical trials are the foundation for introducing better drugs, medical practices, and devices. The fact that it involves law and ethics makes it a challenge for those who frame the legal provisions. The Ministry of Health and the DCGI must leave no room for complacency when it comes to human trials and ensure that gaps are plugged by ensuring uniformity and the removal of ambiguity from existing regulations. However, the law has the power to regulate, monitor and guarantee the protection of subjects only up to a certain point.

With the change in global regulatory standards, outsourcing regulatory affairs work seems like a more beneficial option both in terms of time and money. Maintaining a large regulatory affairs department can be very expensive and the scope of knowledge can be limited to certain aspects. On the other hand, a regulatory affairs consultant continues to keep up to date with current regulations and has vital experience in the field to streamline the approval process.

Pharmaceutical regulatory affairs involve both investigational new drugs (INDs) and generics. Well-established regulatory firms can provide services in the following ways:

Compilation and formulation of large regulatory requests for the presentation of both APIs in different countries, commonly referred to as dossiers.

Experience in normative and scientific knowledge.

Experience, knowledge and support in terms of the local regulatory authority.

Expert solutions for inquiries from the FDA and other regulatory agencies. Access to scientific and technical resources.

Formulation and implementation of regulatory strategies at a global level.

The Regulatory Affairs unit in the pharmaceutical industry acts as the backbone for its survival. It relates to the implications for public health, standard setting and intellectual property rights in drug development, the public responsibility of regulatory agencies, the procedures used by pharmaceutical companies for regulatory compliance, and addresses the complex web of regulatory requirements, application processes and quality control. issues influencing the pharmaceutical industry.

On the other hand, a regulatory firm will speed up the filing process in conjunction with the active participation of the client (party that hires the regulatory firm). Once established, the service offered by the regulatory affairs professional can help the business save time and money. Henceforth, a proper selection of regulatory professionals is very important. Consultants should have experience in the preparation and submission of regulatory documents and extensive knowledge to obtain approval for various drugs, and be able to formulate and implement regulatory strategies. Professional references, documents produced, approvals obtained, and articles published by them can be better sources to evaluate your experience.

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