New Drug is any molecule or Fixed Dosed Combination (FDC) which is registered for the first time in India. The registered drug is referred to as a “New Drug” for 4 years after the date of first approval. The first application requires a clinical trial, whereas the subsequent applications can just go with the Bioequivalence (BE) studies which are much cheaper and faster.
Who regulate drugs approval in India?
In India, Indian Parliament proclaimed The New Clinical Trial Rules & Amendment 2022 in order to regulate the import, manufacturing, distribution, and sales of new drugs. CDSCO is India’s drugs regulatory body for pharmaceuticals, medical devices, and cosmetics was established along with its licensing authority, the Drug Controller General of India (DCGI).
How Do New Drugs Impact Business?
New Drugs helps to create a portfolio of uncommon, new, and trending products.
Big pharma and marketing partners often look for the manufacturers with new drug or products
The DCGI publishes a list highlighting companies that have received New Drug Approvals, which can benefit the branding of the company
With the new drugs the company can standout and it will help in extra edge over other companies. There are not many companies that have the resources for filing New Drug Application.
How Regulatory Specialists help in Regulatory Filings?
Regulatory affairs play an important role in the pharmaceutical industry to oversee the sanctity of the procedure and the formulation of a drug. In terms of regulatory filings, the procedure of the drug passing through regulation from the date of filing till approval is a hectic and elongated procedure. Applying a new drug for approval demands a variety of different documentation. Primarily, there are two reasons behind the failure of drug applications, one of them being unsatisfactory information provided to the regulatory body and the other being inadequate drug performance. Thereby refining and executing the regulatory strategies in an organized manner becomes necessary to achieve a positive resolution.
To guide companies or organizations through these procedures is where a regulatory specialist turns out to be useful. A regulatory consulting specialist works by helping a company or organization meet the necessary regulations that are required for its products. The following are some of the tasks and responsibilities of regulatory specialists:
Providing a deep understanding of new and existing regulations impacting the organization’s products and procedures
Establishing clearly documented protocols
Explaining regulations, procedures, and policies to the employees and stakeholders as necessary
Reviewing marketing, legal, and technical documentation to assess compliance
Regularly reporting on compliance status and measures to both internal and external parties
Acting as a link between the organization and the state, local, federal, or international agencies in order to submit the required forms and paperwork in a simplified manner
How can Rihim Pharma help you?
Developing a new drug not only takes a lot of resources but a great amount of effort added to it and thereby taking a drug to its end goal, the consumers, demands a lot of effort and patience. Any new drug in India must follow a specific procedure and submit several documents in order to be approved by the CDSCO. We at Rihim Pharma will help guide you through each stage of this procedure. Rihim Pharma is determined to provide a simpler and hassle-free experience to our clients. Here is a glimpse of some of the services you will receive from our end:
New Drug suggestions based on existing portfolio and manufacturing capabilities
Managing end-to-end regulatory affairs from the compilation of the documents to submission and approval
Help in sub-contracting CT/BE/Toxicity studies and with our great experience in SEC, we can help you prepare for the SEC
GAP analysis of documents to reduce queries in NDA
Creating a regulatory strategy that gives your business an edge
Rihim is doing this for over 500+ Pharma Companies, see our clientele
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