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.
Most of our work is with Indian manufacturers meeting Revised Schedule M, which has applied since 1 January 2026. The engineering half of compliance — air handling, water systems, clean rooms — belongs to engineering firms. The documentation half is ours: the gap assessment against the revised schedule, the pharmaceutical quality system, quality risk management, product quality review, the site master file, validation protocols and the data-integrity framework.
For exporters we work on rules of origin and destination-market registration. Every trade agreement India has signed uses a different origin test, and since 15 July 2026 origin under the United Kingdom agreement is self-certified by the exporter, who then carries five years of audit exposure. We establish whether a product qualifies, build the costing file behind it, and put the record-keeping in place. The Gulf agreements give a 90-day registration route for products already approved by a reference regulator, and the qualifying lists differ between them.
We also act for sponsors outside India who are running clinical trials here. A sponsor without an Indian entity files through one, and we take that role. The reason to give it to us rather than to a firm already working on the study is that we have no other interest in it: a contract research organisation that is also your regulatory face has a commercial position in the scope of your trial, and an importer holding your regulatory identity has one in your product. We do neither.
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 reference material for anyone who wants to understand the sector we work in.
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.