Getting a COPP Certificate in India
How do I get a COPP certificate in India?
In India you apply for a WHO-GMP Certificate of Pharmaceutical Product (COPP) to your State Licensing Authority (SLA). Since 15.08.2025, the application must go through CDSCO's online ONDLS portal; CDSCO no longer accepts paper files [1]. The certificate is granted after the CDSCO zonal or sub-zonal office and the SLA review your documents and, where required, inspect your site jointly [2].
What a COPP is for
- CDSCO lists COPP inspections as being "as per WHO Certification Scheme for use in international commerce only" [3].
- A 2012 Health Ministry clarification states that COPPs, GMP certificates and Free Sale Certificates for export "are not issued under the Drugs & Cosmetics Act, 1940". Exporters still have to meet the importing country's requirements [4].
Step 1: Set up on ONDLS before you apply CDSCO's annexed procedure says your licence and product details must be approved on ONDLS before you can file a COPP application [5]:
- Register the manufacturing site.
- Register the technical staff currently on your licence.
- Add your licensed products and basic licence data from the old licence records.
- Submit the licence data to your SLA.
- Once the SLA approves it, a new number is generated against your old licence number. You can then file the COPP application.
Timeline of the switch to online filing
- The June 2025 circular made ONDLS filing mandatory from 15.07.2025 [6].
- That deadline was extended to 15.08.2025 [7].
- An August 2025 reminder confirmed no further extension and no physical applications after that date. Portal support: CDAC (ondlssupport-noida@cdac.in) and the CDSCO IT cell (it-cell@cdsco.nic.in) [1].
Step 2: Documents (CDSCO circular of 3 March 2020) The applicant "shall submit" the application with a checklist (Annexure A) and a Product Summary Sheet (Annexure B) [2].
- Annexure A covers:
- the application from the manufacturer
- a Site Master File (WHO TRS 961, Annex 14)
- a copy of the manufacturing licence
- a list of approved products and a list of products you want COPPs for
- lists of SOPs and STPs
- stability data for 3 batches (accelerated or real time)
- a list of equipment and instruments
- technical staff qualifications and approval status, plus an organogram [2]
- the manufacturing layout plan
- process validation for 3 batches of each product
- water-system and HVAC schematics, if they are not in the Site Master File [8]
- Annexure B, per product, covers: batches made in the last two years (with scale), stability studies, process and analytical method validation status, and whether DCGI has approved the product [8].
Step 3: Review, inspection and issue
- First-time applicants: CDSCO zonal or sub-zonal officers and the SLA plan a joint inspection after reviewing Annexures A and B. The COPP is issued once you have corrected any deficiencies found [8].
- Inspection standard: the inspection follows the 47th DCC minutes and current WHO TRS GMP guidelines. Deficiencies are categorised under WHO TRS 996, Annex 4 [9].
- Adding products: if CDSCO and the SLA jointly inspected your site within the last two years and found it compliant, a COPP for an additional product is issued once you provide the complete Annexure B data [8].
- Timelines, counted from receipt of a complete application: the CDSCO office sends its recommendation to the SLA within 21 working days if no joint inspection is needed, or 28 working days if one is. The COPP is then issued within 5 days of the joint inspection team's recommendation [8].
- Same route for: grant, revalidation and additional products [2].
Ayurvedic products CDSCO inspects Ayurvedic manufacturers for COPP together with staff of the AYUSH Ministry and the State AYUSH Authority, and posts the list of COPP holders on its website [10]. Past CDSCO lists of Ayurvedic COPP holders under the WHO GMP Certification Scheme are published [11]. I found no separate AYUSH application procedure in the sources.
Not found: the government fee for a COPP and its validity period are not stated in any of the circulars I found, so I can't give either figure.
Approach: I searched CDSCO's circulars and public notices, its COPP publications (including the Ayurvedic COPP lists), and the Drugs Rules, 1945 (CDSCO's 2024 consolidation). The detailed ONDLS user guide is not in the sources I can search.
Is the process different for Ayurvedic medicines?
Yes. The basic route is the same: it is a WHO-GMP/CoPP certificate issued by CDSCO. For Ayurvedic, Siddha and Unani (ASU) medicines, though, the Ministry of AYUSH takes part in the inspection, the checklist has several herbal-specific items, and the application goes to a different office. CDSCO's own description of the work is "Inspections of Ayurvedic medicine manufacturers for grant of Certificate of Pharmaceutical Products (COPP) along with personnel of AYUSH Ministry and State AYUSH Authority and work related to issuance of COPPs" [10]. A Ministry of AYUSH statement to the Rajya Sabha in March 2026 says CDSCO has an Ayush vertical and "issues WHO Certificate of Pharmaceutical Product (WHO-CoPP) to Ayush drugs" that meet the standards (PIB, 18 Mar 2026).
How it differs from the allopathic route
| Point | Allopathic (March 2020 circular) | ASU / herbal |
|---|---|---|
| Who inspects | CDSCO zonal or sub-zonal office with the State Licensing Authority [8] | CDSCO with staff from the AYUSH Ministry and the State AYUSH Authority [10] |
| GMP standard | WHO TRS guidelines; deficiencies graded under TRS 996 Annex 4 [9] | ASU manufacturers must comply with GMP under Schedule T of the Drugs Rules, 1945 and with the relevant pharmacopoeial standards (PIB) |
| Where to apply | Through the zonal office and SLA; ONDLS from 15.08.2025 [1] | The ASU checklist says to address the application to the Office of DCG(I), CDSCO (HQ), New Delhi, with a copy to the Drug Control Cell, Ministry of AYUSH |
| Site Master File basis | WHO TRS 961, Annex 14 | WHO TRS 823 |
Extra documents on CDSCO's ASU checklist CDSCO published this checklist for public comment on 14 May 2018 and labelled it a "draft checklist" (CDSCO checklist PDF). I found no later final version.
Many items match the allopathic Annexure A: licence, Site Master File, 3-batch stability and process validation, SOPs and STPs, layout, water and HVAC diagrams, and a product summary sheet. The checklist also asks for:
- the master manufacturing formula, finished product specifications and analytical method validation
- export data for the last 2 years, when revalidating a CoPP
- the actual labels of the products
- proof of safety and effectiveness under Rule 158B of the Drugs & Cosmetics Rules, 1945
- reference standards for the ingredients or formulation
- Certificates of Analysis for three batches of each product
- an undertaking that the products contain no non-herbal ingredients, including metals or minerals
- an undertaking that you comply with Indian law, including the Drugs & Cosmetics Act, 1940 and the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954
The ASU product summary sheet (Format B) also asks for cleaning validation status, availability of reference and working standards, annual product review, and the product permission.
Validity seen in practice CDSCO's published lists of Ayurvedic COPPs show the validity period changing over time:
- September 2017: "Two Years from the date of issuance (subject to the validity of manufacturing License whichever is less)" [11].
- June 2018: "Three years from the date of issue" on the same condition [12].
These are only the terms recorded on past grants. I found no rule that sets the period.
Still open:
- I found nothing saying whether the 2025 ONDLS online-filing rule covers ASU COPP applications.
- I found no later replacement for the CDSCO (HQ) addressing in the 2018 draft.
- No AYUSH-specific timelines or fees were stated in any source I found.
Approach: I searched CDSCO's circulars, public notices and Ayurvedic COPP lists, then opened CDSCO's ASU checklist and a Ministry of AYUSH statement on PIB. The checklist I could open is the 2018 draft.