We help in product selection, strategizing and guide our clients through the entire process of new drug approval.
New Drug Approval
India is a country which has a drug regulatory system operating at the Central Level as well as the State Level. At Central level, Central Drugs Standards Control Organization (CDSCO) is the organization which has been given the prime responsibility of approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. On 19th March, 2019 vide G.S.R. 227 (E), India has published new set of regulations which are applicable for all types of new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. These rules are known as New Drugs and Clinical Trial Rules, 2019. We help our clients in strategizing, formulation development, dossier preparation, filing and resolving queries. We help our clients understand the requirements of the drug approval process, so that there is no ambiguity or confusion in the process to follow. This makes their new drug approval experience stress free. Transparency and accountability are basic principles imbibed in the team handling new drugs approval.
India is a country which has a drug regulatory system operating at the Central Level as well as the State Level. At Central level, Central Drugs Standards Control Organization (CDSCO) is the organization which has been given the prime responsibility of approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. On 19th March, 2019 vide G.S.R. 227 (E), India has published new set of regulations which are applicable for all types of new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. These rules are known as New Drugs and Clinical Trial Rules, 2019. We help our clients in strategizing, formulation development, dossier preparation, filing and resolving queries. We help our clients understand the requirements of the drug approval process, so that there is no ambiguity or confusion in the process to follow. This makes their new drug approval experience stress free. Transparency and accountability are basic principles imbibed in the team handling new drugs approval.
As per Rule 2 (w) of New Drugs and Clinical Trial Rules, 2019, the New Drug means:
- a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labeling thereof and has not been approved as safe and efficacious by the Central Licensing Authority with respect to its claims; or
- a drug approved by the Central Licensing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or
- a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or
- a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority; or
- a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal antibodyanti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug;
India has a federal structure where there is a power sharing between the central authorities and the state authorities. Even in the drug approval process there are different stages where you need approval from Central authorities and at certain stages approval from state authorities are desired.
At API First, we solve this puzzle for you. We provide a clear pathway for our Indian manufacturers, Overseas manufacturers as well as importers so that the complete drug approval becomes hassle free and expedited. We strategize, prepare dossiers and file applications. We follow-up the applications till their approvals.
List of various services being handled by Vaayath in drug approval process is as follows:
- New Drug Approval
- Investigational New Drug Approval
- Subsequent New Drug Approval
- Approval of Fixed Dose Combinations
- NOC for conducting clinical trial
- NOC for conducting BA-BE
- BE NOC for export
- Toxicity Studies
- Special code/ Neutral Code
- Export NOC
- Dual use NOC
- NOC for test license
- Form 29 for test batches
- Manufacturing License
- Free Sale Certificate
For overseas manufacturers and importers, we go up a notch higher with our support services. We at API First understand that any overseas manufacturer looking forward to India as a prospective market faces many questions with respect to regulatory procedures. We ensure that their access to the Indian market is smooth. Services offered to overseas manufacturers and importers are as follows: