Today, Regulatory Affairs is a dynamic business unit that works with a focus to get products to the market with commercially viable label in the least possible time and expenses. 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 is to be sold. Various government agencies are involved in regulating drugs within their market. Some of them include:
USFDA-US, EMEA-Europe, TGA-Australia, and MHRA-UK and TPD-CANADA.
Patent expiries, tightening healthcare budgets and a stricter regulatory climate are the major challenges to the pharmaceutical industry. Many companies are in a race to place their new products in the world market and to gain market share and increase earnings.
In such a scenario a small delay in gaining market access means huge loss in terms of market share and revenue generated. The keys to success for pharmaceutical companies lie in obtaining timely marketing approval from regulators. So, to obtain timely marketing approval, companies can either strengthen their regulatory department or outsource the same to regulatory affairs consulting firm.
Present Regulatory Scenario
The principal legislation governing clinical trials is the Drugs and Cosmetics Act, 1940 and the Directorate authority is the Drugs Controller General of India (DCGI). Schedule Y to the Drugs and Cosmetics Rules, 1945 stipulates the regulations for importing and manufacturing new drugs for sale and to undertake clinical trials in India. Additionally, the Indian Council of Medical Research (ICMR) has issued Ethical Guidelines for Biomedical Research on Human Participants and the Central Drugs Standard Control Organization has formulated Good Clinical Practices Guidelines (GCP Guidelines) in line with the international guidelines issued by World Health Organization and International Committee on Harmonization (ICHGCP), which provides operative guidelines for ethical and scientific standards for the designing of a clinical trial protocol including conduct, recording, safety and reporting procedures. It is compulsory for every organization undertaking a clinical trial in India to strictly adhere to these guidelines.
One cannot deny the fact that clinical trial is the basis for introducing better drugs, medical practices, and devices. The fact that it involves law and ethics makes it a challenge for those framing the legal provisions. The Ministry of Health and the DCGI should leave no room for complacency when it comes to human trials and ensure that the loopholes are plugged by ensuring uniformity and removal of ambiguity from the existing regulations. However, law has the power to regulate, monitor, and ensure protection of subjects only to a certain extent
With changing global regulatory norms, outsourcing regulatory affairs work seems a more beneficial option both in terms of time and money. Maintaining a large regulatory affairs department can be very expensive and scope of knowledge can be limited to certain aspects. On the other hand, a regulatory affairs consultant keeps on updating himself with the current regulation and has vital experience in the field to expedite the approval process.
Pharmaceutical Regulatory Affairs involves both Investigational New Drugs (IND) & Generics. Well-established regulatory firms can provide service in the following ways:
Compilation and formulation of large regulatory application for submission for both APIs in different countries, commonly called, as dossiers.
Expertise in regulatory and scientific knowledge.
Expertise knowledge and support in terms of local regulatory authority.
Expert solutions to FDA and other regulatory agencies queries. Access to scientific and technical resources.
Formulation and implementation of regulatory strategies at a global level.
Regulatory Affairs unit in Pharmaceuticals 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, public accountability of regulatory agencies, procedures utilized 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 accelerate the submission process in tandem with active participation of the customer (party hiring the regulatory firm). Once it is established the service offered by regulatory affairs professional can help company save both time and money. Hence forth, a proper selection of regulatory professional is very important. Consultants should have experience in preparation and submission of regulatory documents and extensive knowledge in getting approval for various drugs, and be able to formulate regulatory strategies and implement them. The professional references, documents prepared, approvals obtained, and articles published by them can be better sources to evaluate their experience.