About
We act for pharmaceutical companies that need something done in India, or need something kept in order once it has been approved. We are small, we work directly with the people who own the file, and we say what we will not take on.
Our first work is regulatory support for clinical trials run in India by sponsors based elsewhere. Under the New Drugs and Clinical Trials Rules 2019, a sponsor without an Indian entity cannot deal with the regulator directly — submissions, queries, safety reporting and the compensation process all run through a party established here. We take that role: acting as the sponsor’s authorised representative, preparing and filing the clinical trial application with the Central Drugs Standard Control Organisation, assembling ethics committee submissions for each site, and applying for the licences that allow investigational product to be imported.
Alongside that we do post-approval maintenance for companies exporting finished medicines: variation dossiers when a site or a specification changes, renewals to each market’s own timetable, and gap reviews of dossiers that have fallen behind the requirements of the market they sit in. It is unglamorous work, it recurs for the life of a product, and it is the work large firms are least interested in doing carefully.
We also prepare filings ahead of patent expiry, so that a company is ready to file on the day exclusivity ends rather than starting then. Where a question becomes a legal one — a patent challenge, a certification — we say so and refer it to counsel.
We advise on trials; we do not run them. We do not monitor or manage sites, which are delegated duties requiring a registration we do not hold. We do not hold a marketing authorisation, act as a local representative for a marketed product, or serve as an authorised agent in any market. We do not develop biosimilars. We do not conduct patent litigation. Where work falls outside what we do, we will tell you rather than take it and subcontract it.
Variation dossiers and renewal submissions are quoted as a fixed fee per dossier, per market — not by the hour. Change-classification opinions are a flat rate. You receive a written quote before any work begins, and it does not move unless the scope does. We do not bill for time spent understanding your product.
This site also carries a compilation of India’s pharmaceutical export, patent and destination data, drawn from official statistical sources and public filings. It is background and context for anyone who wants to understand the sector we work in. It is not a product, and nothing we do depends on it.
It is a fixed compilation and is not updated. The figures are published as at the dates stated with them, and any figure being relied on should be checked against the issuing agency. The sources, the bases and the as-of dates are set out on the data and sources page.
Dual-source profiles. Where a destination country publishes its own import data — the mirror or partner statistics — both sides are shown. Partner data often captures shipments that India’s own record misses, and the reverse is also true. Neither is treated as correcting the other.
Fiscal against calendar year. India’s trade data follows the fiscal year, April to March, labelled by the ending year: FY 2025–26 covers April 2025 to March 2026. Partner-country data follows the calendar year. Where both appear on the same page, the basis is labelled.
Product classification. Exports are classified at the tariff-line level and grouped into five categories — formulations, bulk drugs and intermediates, vaccines, surgicals, and traditional medicine — following the taxonomy used by the Pharmaceuticals Export Promotion Council of India.
Currency. All trade values are in US dollars. India’s figures are reported in rupees at source and converted at the Reserve Bank of India reference rate for the corresponding month. Partner-country data is reported in dollars at source.
Bharat WorldMeds publishes compiled data on India’s pharmaceutical exports alongside its regulatory services. It is not affiliated with, endorsed by, or connected to any other company, pharmacy, or platform with a similar name.
Bharat WorldMeds is not affiliated with, endorsed by, or connected to PhRMA (the Pharmaceutical Research and Manufacturers of America), any government agency, or any pharmaceutical company. All data is sourced from official government statistical agencies and publicly available company filings as described above. While every effort is made to ensure accuracy, this site is provided for information and does not constitute regulatory, legal or commercial advice.