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ind fda meaning: India: Indian drugmakers switching to fresh strategies as US amends norms

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The World Health Organization , which co-leads COVAX, has been pushing India to resume supplies for the programme, particularly after it sent ~4 million doses to neighbours and allies in October 2021. The National Digital Health Blueprint has the potential to generate nearly US$ 200 billion in added economic value for India’s healthcare industry over the next 10 years. In April 2022, Dr Reddy’s Laboratories Ltd. inked a pact with MediCane Health to announce the launch of medical cannabis products in Germany. Glenmark becomes the first pharmaceutical company to launch Indacaterol + Mometasone fixed-Dose combination drug for Asthma in India.


Common technical document for the registration of pharmaceuticals for human use. 100% FDI in the pharmaceutical sector is allowed in brownfield pharmaceuticals; wherein 74% is allowed under the automatic route and thereafter through the government approval route. Indian pharma companies enabled by their price competitiveness and good quality, have made global mark, with 60% of the world’s vaccines and 20% of generic medicines coming from India. The FDA reviews all the data submitted, and approves the drug for marketing if the data is found worth.

Gracell Biotechnologies Announces FDA Clearance of the IND … – PR Newswire

Gracell Biotechnologies Announces FDA Clearance of the IND ….

Posted: Fri, 03 Feb 2023 08:00:00 GMT [source]

Studies generally conducted under a traditional IND include pharmacokinetic and pharmacology studies to evaluate different dosing schedules or routes of administration, such as tests of animal absorption, distribution, metabolism, and excretion, analytic assays, and drug formulation testing. Both INDs require single-dose toxicology studies in two mammalian species to determine toxic and safe doses. In 2001, US FDA gave RLF-100 an orphan drug designation to treat acute respiratory distress syndrome, and in 2006 for acute lung injury. US FDA also granted investigational new drug licenses for human trials of Aviptadil. But it has not shown significant progress in those trials in treating lung diseases.

Medical tourism

In August 2021, Uniza Group, an Ahmedabad-ind fda meaning pharmaceutical firm, signed an agreement with Lysulin Inc. (an US-based firm) to introduce Lysulin, a nutritional product for Indian consumers. Dr. Reddy’s Laboratories announced the launch of Lenalidomide Capsules in the U.S. with two of six strengths eligible for first-to-market, 180-day exclusivity in September 2022. The International Conference on Harmonisation of technical requirements for registration of Pharmaceuticals for human use. The CDP scheme is implemented on a Public Private Partnership format through one-time grant-in-aid with aim to enhance Quality, productivity & Innovative capabilities of the SME Pharma sector in the country. Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events.

  • India is among the top 10 pharmaceutical exporting countries with its share of the global market on the rise compared to the previous 5 years.
  • During the absence of inspections in the past two years, the competition had increased in the existing ANDAs and the proportion of new ANDA approvals to existing approvals had fallen , resulting in pricing pressure becoming much more pronounced.
  • India supplies over 50% of Africa’s requirement for generics, ~40% of generic demand in the US and ~25% of all medicine in the UK.
  • If the results are promising, the sponsor of the product would use the trial and other information in its application to bring the product to the market.
  • IDFC Securities’ pharma analyst Nitin Agarwal said the value of the 180-day market exclusivity, which is considered the holy grail of the US generics market, now stands “considerably diminished” thanks to growing competition among players.
  • Phase-IV trials are done to determine if a drug or treatment is safe over time , or to see if a treatment or medication can be used in other circumstances.

Going forward, better in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers, which are on the rise. The Indian Government has taken many steps to reduce costs and bring down healthcare expenses. The National Health Protection Scheme, which aims to offer universal healthcare, the ageing population, the rise in chronic diseases, and other government programmes, including the opening of pharmacies that offer inexpensive generic medications, should all contribute to boost the Indian pharmaceutical industry. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies.


As the fight between Google and the Competition Commission of India reaches the Supreme Court, the tech giant on Friday said India is at a juncture where the stakeholders must come together to bring down barriers to access and… It says, “With earnings before interest, taxes, depreciation, and amortisation margins and returns from the US business remaining muted, diversification into other markets has resulted in the contribution from the US declining to 32% in the first half of FY22-23 from 39% in FY16-17, providing cushion to any potential disruption on account of OAIs.” India also accounts for ~60% of global vaccine demand, and is a leading supplier of DPT, BCG and Measles vaccines.

iTolerance, Inc. Completes Pre-IND Meeting with U.S. FDA for … – AccessWire

iTolerance, Inc. Completes Pre-IND Meeting with U.S. FDA for ….

Posted: Wed, 01 Mar 2023 15:03:25 GMT [source]

In August 2021, Union Health Minister, Mr. Mansukh Mandaviya announced that an additional number of pharmaceutical companies in India are expected to commence manufacturing of anti-coronavirus vaccines by October-November 2021. This move is expected to further boost the vaccination drive across the country. The Union Cabinet has given its nod for the amendment of existing Foreign Direct Investment policy in the pharmaceutical sector in order to allow FDI up to 100% under the automatic route for manufacturing of medical devices subject to certain conditions. The Indian drugs and pharmaceuticals sector received cumulative FDIs worth US$ 19.41 billion between April 2000-March 2022. The FDI inflows in the Indian drugs and pharmaceuticals sector reached US$ 19.90 billion between April 2000-June 2022.

Industry Scenario

The rating agency expects Indian pharmaceutical companies to continue to benefit from increasing sales contribution of the domestic markets even as growth in the export markets could remain flat in FY22-23. Gross margins for the companies exposed to exports could come under some pressure, it says, adding, API manufacturers will see significant capex on account of the production-linked incentive schemes. Food and Drug Administration has cleared the company’s Investigational New Drug application for NTLA-2002 for the treatment of hereditary angioedema , enabling the company to include the United States in the global Phase 2 portion of its ongoing Phase 1/2 study. NTLA-2002 is an in vivo genome editing candidate designed to inactivate the target gene, kallikrein B1 , to permanently reduce plasma kallikrein protein activity and thus prevent HAE attacks after a single-dose treatment. Indian drugs are exported to more than 200 countries in the world, with US being the key market.

India is among the top 10 pharmaceutical exporting countries with its share of the global market on the rise compared to the previous 5 years. Adani Group stocks rallied for the fourth consecutive day on Friday after the promoters raised ₹15,446 crore by selling stakes in four companies to US-based investment firm GQG Partners on Thursday. I think it’s a very informative post for those who want to get a job in regulatory affairs department.

The pharmaceutical industry in India is a significant part of the nation’s foreign trade and offers lucrative potential for investors. Millions of people around the world receive affordable and inexpensive generic medications from India, which also runs a sizable number of plants that adhere to Good Manufacturing Practices standards set by the World Health Organization and the United States Food and Drug Administration . Among nations that produce pharmaceuticals, India has long held the top spot. Medicine spending in India is projected to grow 9-12% over the next five years, leading India to become one of the top 10 countries in terms of medicine spending.


The safety surveillance is designed to detect any rare or long term adverse effects over a much larger patient population and longer period of time than in phase I, II and III trials. Phase-III trials present a bridge between clinical research and the application of its experience in clinical practice. It is, therefore, essential that the experience from a phase III trial is applicable to a broad population of patients. A product that successfully comes through a phase-II trial may be put into a Phase-III clinical trial. Once the new chemical entity has been discovered, an extensive laboratory research is conducted in-vitro and in-vivo, to evaluate the pharmacologic and toxicological parameters. After the completion of pre-clinical studies, an IND is filed with the FDA in the United States.

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Within 24 hours of the third infusion, substantial improvement in oxygen saturation and radiographic improvement in characteristic COVID-19 pneumonitis was noted. He was discharged from intensive care at that point and returned home at 1 week on room air,” a multi-author article by doctors stated. FULFILLING GLOBAL DEMAND India is the largest producer of generic drugs in the world. In September 2021, the Indian government contributed US$ 4 billion to the pharmaceutical and medical industries. The Indian pharmaceutical industry generated a trade surplus of US$ 15.81 billion in FY22. Low cost of production and R&D boosts efficiency of Indian pharma companies, leading to competitive exports.


India is a major exporter of Pharmaceuticals, with over 200+ countries served by Indian pharma exports. India supplies over 50% of Africa’s requirement for generics, ~40% of generic demand in the US and ~25% of all medicine in the UK. Google Translate – an automatic translation service that uses state-of-the-art technology, not human translators, to translate text – provides instant translations in different languages. By providing these translations, we hope to make essential information available to a diverse range of investors. However, please be aware that, since translations are done by machine, they may not always be perfect.

  • FTFs are the main growth drivers for most leading Indian companies that make generic versions of expensive drugs that have gone off patent.
  • If new drug fails to reach market, this usually occurs during this phase of clinical trial.
  • In August 2021, Union Health Minister, Mr. Mansukh Mandaviya announced that an additional number of pharmaceutical companies in India are expected to commence manufacturing of anti-coronavirus vaccines by October-November 2021.

FTF refers to drugs whose generic, or low-cost, versions can be launched by a drugmaker who enjoys an 180-day exclusive marketing period during which no other generic versions can be sold. Ans-It is the commonly used name for the book “Approved Drug Products Equivalence Evaluations”, which is published by USFDA.It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act. The pharmaceutical industry in India is expected to reach $65 Bn by 2024 and to $130 Bn by 2030.

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