Regulatory guide · Drugs and Cosmetics Rules, 1945
Agreement for marketing format under Rule 84D: what the 2020 amendment requires
Short answer. Since 1 March 2021, a marketer who puts its own name on a drug made by another manufacturer must first sign an agreement for marketing with that manufacturer (Rule 84D). The marketer is responsible for the drug’s quality and other regulatory compliances along with the manufacturer (Rule 84E), and its name and address must appear on the label (Rule 96(1)(xiii)).[1][2]
The sources reviewed describe the requirement as an agreement that must exist, and do not list mandatory clauses.[3] Any agreement for marketing format, including the sample and the PDF download further down, is therefore a commercial template, not a statutory form.
Which route are you on?
Rule 84D applies when you adopt a drug made by another manufacturer by labelling it with your name. Answer two questions to see whether it applies to you. The other common route is a loan licence, where the licensee holds the manufacturing licence itself and keeps responsibility for quality.[11]
1. Whose name will appear on the label?
2. Who holds the manufacturing licence for the product?
Answer both questions
Pick one option in each group and the result appears here. It is a starting point, not legal advice.
What G.S.R. 101(E) changed
The Drugs and Cosmetics (Amendment) Rules, 2020 were notified as G.S.R. 101(E) dated 11 February 2020 and came into force on 1 March 2021.[1][2][3] They changed four things in the Drugs and Cosmetics Rules, 1945:
| Provision | What it says |
|---|---|
| Rule 2(ea) | Defines a “marketer”: a person who, as an agent or in any other capacity, adopts a drug made by another manufacturer under an agreement for marketing, by labelling it or affixing his name on the label, with a view to its sale and distribution.[1][2] |
| Rule 84D | A marketer may not adopt a drug made by another manufacturer, by putting his name on its label for sale and distribution, without an agreement.[1][3] |
| Rule 84E | A marketer who sells or distributes any drug is responsible for its quality and other regulatory compliances along with the manufacturer.[1][2] |
| Rule 96(1)(xiii) | The label must carry the marketer’s name and address where a marketer is involved. For ampoules and similar small containers, only the marketer’s name is required.[1] |
Two limits on what the Rules do. “Along with the manufacturer” means shared responsibility toward the regulator; the Rule does not say the shares are equal. And third-party manufacturing did not become illegal: a marketer can still use another manufacturer’s licensed facility, provided the Rule 84D agreement exists.
Agreement for marketing format: sample and free PDF download
Download the October 2026 edition (PDF)
A fuller agreement for marketing format than the 11-clause sample below: 16 clauses, three annexures (products, commercial terms, who does what) and a page listing what changed since 2021. It adds:
- a manufacturer licence, GMP and sourcing clause, reflecting revised Schedule M[9][10] and the CDSCO advice to use pharma-grade excipients from approved sources[14];
- labelling and artwork approval, including bar code or QR code where Schedule H2 applies (G.S.R. 823(E), 17 November 2022, from 1 August 2023);[13]
- regulatory cooperation under Rule 84E, back-to-back indemnity and a recall clause with two options;[3]
- price control wording for DPCO 2013 as amended,[5][6] and promotion wording that names UCPMP 2024;[8]
- a choice between court jurisdiction and arbitration.
Download the agreement for marketing format (PDF)
Free, no sign-up, 9 pages, A4. Copy the text into your own document or print it and complete the highlighted fields, then have an advocate vet it before signing.
The core 11-clause agreement for marketing format, corrected
Fill the highlighted fields, then have an advocate vet the final text. Clauses 1, 6 and 7 are updated from the earlier version of this page; the update log lower down lists what moved.
AGREEMENT FOR MARKETING
This Agreement (the “Agreement for Marketing”) is made on the ____ day of __________ 20__ and is effective from __________ 20__.
BETWEEN
[NAME OF MARKETER], having its registered office at [COMPLETE ADDRESS] (hereinafter referred to as “Marketed By”), which expression shall, unless repugnant to the context or meaning thereof, be deemed to include its successors, permitted assigns, marketing divisions, subsidiaries, godowns and associate firms;
AND
[NAME OF MANUFACTURER], a [company / firm / LLP] having its manufacturing premises at [COMPLETE ADDRESS OF MANUFACTURING SITE] and holding manufacturing licence no. [____] (hereinafter referred to as the “Manufacturer”), which expression shall, unless repugnant to the context or meaning thereof, be deemed to include its successors and permitted assigns.
NOW THIS AGREEMENT WITNESSETH AS FOLLOWS:
1. The Drugs and Cosmetics (Amendment) Rules, 2020, notified by the Ministry of Health and Family Welfare, Government of India, vide G.S.R. 101(E) dated 11 February 2020 and in force from 1 March 2021, inserted Rules 84D and 84E in the Drugs and Cosmetics Rules, 1945. Rule 84D requires an agreement between a marketer and the manufacturer whose drug the marketer adopts. This Agreement is made for that purpose.
2. The name of the Manufacturer, with its complete address and manufacturing licence details, shall appear on all goods supplied by the Manufacturer.
3. The name of “Marketed By”, with its complete address, shall appear on all goods supplied by the Manufacturer. “Marketed By” shall maintain the address printed on the products and ensure that any communication sent to that address is duly received and is not refused or returned undelivered for any reason. If a communication is refused or not delivered, the address to which the Manufacturer raises its invoice on “Marketed By” shall be treated as the address of “Marketed By” for all purposes.
4. “Marketed By” is solely responsible for the trade marks and brand names (registered or unregistered), company name, logo, pack design, artwork, colour pattern and promotional material it adopts on the goods, and these remain the property of “Marketed By” only. If any brand name, pack design, artwork or colour pattern clashes with that of any other person, the Manufacturer shall discontinue manufacture of the disputed product, and “Marketed By” alone shall be responsible for any violation of the Drugs and Cosmetics Act, the Trade Marks Act, 1999, the Designs Act, 2000 or the Copyright Act, 1957.
5. Any recall of a drug or fixed-dose combination (including on a ban), the expiry of any drug and its disposal under pollution-control norms are the exclusive responsibility of “Marketed By”. The Manufacturer shall not be responsible for expired goods or their disposal under any circumstances.
6. Where any amount is claimed or recovered under the Drugs (Prices Control) Order, 2013, including an overcharged amount with interest or any amount payable to the Drugs Prices Equalisation Account, on account of the price, MRP or pack instructions given by “Marketed By”, that amount shall be payable by “Marketed By” only.
7. The Manufacturer shall supply drug products to “Marketed By” on mutually agreed terms against confirmed purchase orders of “Marketed By”. The quality of the drug products as manufactured is the responsibility of the Manufacturer. Maintaining the storage conditions stated on the label until the end of the shelf life, including protection against chipping, crushing, transit damage, excessive heat, moisture, seepage or leakage after the goods leave the Manufacturer’s premises, is the sole responsibility of “Marketed By”, and the Manufacturer shall not be held responsible for such deterioration.
8. Advertising or promotion of any product or brand in the Indian market, including compliance with the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, is the exclusive responsibility of “Marketed By”.
9. “Marketed By” shall bear the cost of packing material, one-time development cost and inventory, including on switching off any product, and shall settle these costs with the Manufacturer on mutually agreed terms.
10. This Agreement is valid for a period of 3 years from the effective date and shall thereafter stand renewed for a further period of 3 years. Either party may terminate this Agreement during its existence by giving a minimum of 90 days’ written notice.
11. In case of any dispute between the parties, the competent court at [DISTRICT / CITY OF THE MANUFACTURER] shall have jurisdiction, to the exclusion of any other court in India.
IN WITNESS WHEREOF the parties have signed this Agreement, or have had it signed by an authorised signatory under a resolution, on the date first written above, in the presence of the witnesses named below.
For “Marketed By”
Name: __________
Designation: __________
Address: __________
Authorised signatory: __________
For the Manufacturer
Name: __________
Designation: __________
Address: __________
Authorised signatory: __________
In the presence of two witnesses: 1. __________ 2. __________
Agreement for marketing format clause guide: what is law and what is negotiable
Only the first three clauses track something the Rules require. The rest are commercial allocations between two parties, and they bind nobody else.
| Clause | Subject | Basis | Watch-out |
|---|---|---|---|
| 1 | Recital and purpose | Rules 84D, 84E[1] | Cite G.S.R. 101(E) of 11 February 2020. The earlier format gave 2021 in this clause. |
| 2 | Manufacturer details on goods | Label rules, Rule 96(1) | Check the licence number and address against the licence itself, not a visiting card. |
| 3 | Marketer name, address, service of notices | Rule 96(1)(xiii)[1] | The notice-address fallback is a commercial term. Keep the printed address staffed. |
| 4 | Trade marks, design, copyright | Commercial | Run a trade mark search before artwork is approved; Clause 4 puts every clash on the marketer. |
| 5 | Recall, expiry, disposal | Commercial | As drafted, even a recall caused by a manufacturing defect sits with the marketer. Many parties allocate by root cause instead. |
| 6 | DPCO claims | Commercial | Cannot bind NPPA: the Order defines “manufacturer” to include one who markets.[4] |
| 7 | Supply, quality, storage | Commercial | “Under any circumstances” style wording does not remove the shared exposure under Rule 84E. |
| 8 | Advertising | Commercial | Section 3 of the 1954 Act applies to any person taking part in publication, whatever the contract says.[7] |
| 9 | Packing, development cost, inventory | Commercial | Attach a schedule with items and rates; “mutually agreed” alone invites disputes. |
| 10 | Term and termination | Commercial | 3 + 3 years and 90 days’ notice come from the earlier format. They are negotiable, not statutory. |
| 11 | Jurisdiction | Commercial | Court at the manufacturer’s district is a choice. Some parties prefer arbitration; ask your advocate. |
Scroll sideways on a phone to read the full table.
Drafting suggestions beyond the original agreement for marketing format
These are practice suggestions from the author, not requirements of Rule 84D. Consider whether to add:
- a clause on cooperation in regulatory inspections and the records each party must hand over, since Rule 84E exposes both parties;
- a quality or technical agreement annexure: specifications, change control, batch release, certificates of analysis and retention samples;
- recall handling and cost allocation by root cause;
- back-to-back indemnity for compliance with the Drugs and Cosmetics Act, which law-firm commentary flags as worth renegotiating after 2021;[3]
- a duty to notify the other party of any regulatory action within a fixed number of days.
Who carries what under an agreement for marketing format
- Trade marks, brand names, artwork and promotional material (Clause 4).
- Recall, expiry and disposal of unsold stock (Clause 5).
- DPCO amounts that arise from its own price or MRP instructions (Clause 6).
- Storage and transit conditions after goods leave the factory (Clause 7).
- Advertising and promotion compliance (Clause 8).
- Packing material, development and inventory costs, including on switching a product off (Clause 9).
- Quality of the product as manufactured, and supply against confirmed purchase orders (Clause 7).
- Its own name, address and licence details on the label (Clause 2).
- Stopping manufacture of a product whose brand or pack design clashes with another party’s (Clause 4).
- Maintaining a valid licence and GMP status for the product. Under the revised Schedule M, the compliance deadline for manufacturers with an approved MSME extension was 31 December 2025, and in November 2025 CDSCO asked state regulators to plan inspections. This is the position as reported in those sources; check the current status with CDSCO.[9][10]
- Quality and other regulatory compliances: Rule 84E makes both parties responsible. A contract can move the cost between them but cannot change what the regulator may do.[1]
- Price control: DPCO 2013 defines a manufacturer, for its purposes, as a person who manufactures, imports or markets drugs, so overcharging recovery can reach either party.[4]
- Advertising: Section 3 of the 1954 Act speaks to any person who takes part in publication.[7]
Before you sign the agreement for marketing: a marketer’s checklist
Because Rule 84E ties you to the manufacturer’s compliance, vet the manufacturer as carefully as it vets you.
- Licence and product permissions. Ask for the current manufacturing licence and confirm the dosage form and product are covered.
- GMP status. Ask where the site stands against revised Schedule M. Our Schedule M compliance dashboard tracks the enforcement position.
- Price control. Check whether the formulation is a scheduled formulation under DPCO 2013 before fixing the MRP printed on the label. Our DPCO 2026 ceiling price guide lists the current revisions.
- Brand clearance. Search the trade mark register before artwork is printed.
- Records. Agree who keeps batch records, complaint records and distribution records, and for how long.
Frequently asked questions
The Drugs and Cosmetics (Amendment) Rules, 2020 were notified as G.S.R. 101(E) on 11 February 2020 and came into force on 1 March 2021.[1][2] They inserted Rules 84D (agreement for marketing) and 84E (responsibility of marketer), defined a marketer in Rule 2(ea) and added the marketer to the label under Rule 96(1)(xiii).[1]
Yes, together with the manufacturer. Rule 84E makes a marketer who sells or distributes a drug responsible for its quality and other regulatory compliances along with the manufacturer.[1][3] The Rule does not say the shares are equal and does not decide who bears the cost between the two. That is for the agreement and, in a dispute, for a court.
The requirement, as the sources reviewed describe it, is that an agreement must exist before a marketer adopts the drug. Those sources do not list mandatory clauses.[1][3] Treat the clauses of any format, including the one on this page, as commercial terms, and check the gazette text itself before relying on that reading.
The contract can allocate the cost between the parties, but it cannot bind NPPA. DPCO 2013 defines a manufacturer, for the purposes of the Order, as a person who manufactures, imports or markets drugs, and overcharged amounts on scheduled formulations are recoverable with interest.[4] News reports say the Government amended paragraph 14(2) on 30 June 2026 so that, where a manufacturer shows it complied with the price-dissemination requirements, its liability is limited to stock traded through the distributor or retailer found to have overcharged. Confirm the wording against the gazette notification before relying on it.[5][6]
Section 3 of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 bars advertisements that suggest a drug can be used to procure miscarriage or prevent conception, to improve sexual capacity, to correct menstrual disorder, or to diagnose, cure or prevent the diseases listed in the Schedule to the Act.[7] Promotion to doctors is dealt with separately by the Uniform Code for Pharmaceutical Marketing Practices 2024, issued by the Department of Pharmaceuticals on 12 March 2024, which makes companies accountable for their medical representatives and employees.[8] Clause 8 places advertising on the marketer, but that is only a contract allocation.
There is no single national figure. Stamp duty on an agreement depends on the stamp law of the state where it is signed, so check the current schedule on your state e-stamping portal or ask your advocate. The earlier version of this page said a minimum of Rs. 100; that is not a rule that applies everywhere. Insufficient stamping has consequences: Gujarat guidance, for example, notes that an under-stamped document is not admitted in evidence until the deficiency and penalty are paid.[12]
Yes. The October 2026 edition on this page is a free PDF with highlighted fields, two optional clauses where you choose between alternatives, and three annexures. A PDF cannot be edited directly, so copy the text into your own word processor or print it and complete it. It is a commercial format, not a statutory form, so have an advocate vet the final text before signing. Rule 84D requires an agreement to exist but, in the sources reviewed, does not list mandatory clauses.[1][3]
Need a regulatory second opinion on your marketing arrangement?
Laafon Galaxy supports pharmaceutical companies with compliance assessments, licensing support and inspection readiness across CDSCO and other regulators.
Book a pharmaceutical regulatory compliance consultation
A consultation does not replace legal vetting of the signed agreement by an advocate.
Related on Laafon
Hold the manufacturing licence in your own name instead of marketing another company’s product.
For marketers looking for a manufacturer to supply their brand.
Territory distribution terms, which are a different contract from a marketing agreement.
Check price control before the MRP goes on the label.
What changed in this update (4 October 2026)
- A free PDF download, the October 2026 edition, was added with updates for Schedule M, label bar codes, UCPMP 2024 and the 2026 DPCO amendment.
- The gazette date is stated as 11 February 2020. Clause 1 of the earlier format said 2021 while the reference list said 2020.
- Rules 84D and 84E were inserted, with Rule 2(ea) and Rule 96(1)(xiii). Rule 84C was listed earlier but is not one of the provisions amended.
- “Equal responsibility” now reads “along with the manufacturer”, which is the wording of Rule 84E.
- The earlier page said the 2021 guidelines require specific clauses and that informal third-party manufacturing became illegal. Neither is supported by the sources reviewed, and both are removed.
- Clause 6 now refers to the DPCO 2013 position in full; Clause 7 states that storage responsibility runs from the point goods leave the factory; the effective-date fields are left blank for you to fill.
- The stamp paper answer no longer states a fixed figure. An earlier FAQ on advertising prescription medicines for self-medication could not be traced to a specific rule and was replaced with the 1954 Act and UCPMP 2024 position.
References
The text of G.S.R. 101(E) is read here from legal-database and law-firm reproductions. The official gazette PDF could not be opened for this update; verify the rule text on egazette.gov.in before relying on it.
- TeamLease RegTech. MoHFW notifies the Drugs and Cosmetics (Amendment) Rules, 2020 [G.S.R. 101(E), 11 February 2020]. Available from: teamleaseregtech.com. Accessed October 2026.
- Legitquest. Drugs and Cosmetics (Amendment) Rules, 2020: text and commencement (1 March 2021). Available from: legitquest.com. Accessed October 2026.
- Khaitan & Co. Contract manufacturing of Drugs and Cosmetics: increased liability for marketers from 2021. Available from: khaitanco.com. Accessed October 2026.
- Ministry of Chemicals and Fertilizers. The Drugs (Prices Control) Order, 2013 (paragraphs 2, 14, 22 and 24). New Delhi: Government of India; 2013. Available from: indiacode.nic.in. Accessed October 2026.
- Medical Dialogues. Centre simplifies drug launch process, cuts overcharging liability for pharma companies [DPCO amendment, 30 June 2026]. Available from: medicaldialogues.in. Accessed October 2026.
- Business Standard. Govt tweaks DPCO to limit liability in overcharging cases, ease compliance. 2 July 2026. Available from: business-standard.com. Accessed October 2026.
- Government of India. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, section 3. Available from: indiankanoon.org. Accessed October 2026.
- Press Information Bureau, Department of Pharmaceuticals. Uniform Code for Pharmaceuticals Marketing Practices 2024 (issued 12 March 2024). Available from: pib.gov.in. Accessed October 2026.
- Business Standard. Pharma units likely to face action for Schedule M violations: experts [CDSCO direction of 7 November 2025]. Available from: business-standard.com. Accessed October 2026.
- CliniExperts. Drugs Amendment Rules 2025: extension of timeline for implementation of Schedule M [G.S.R. 127(E), 11 February 2025]. Available from: cliniexperts.com. Accessed October 2026.
- ksandk.com. Contract manufacturing agreement, principal-to-principal and loan licence agreements under drug laws. Available from: ksandk.com. Accessed October 2026.
- inamdarlegal.com. Stamp duty on agreements in Gujarat: 2026 rate guide. Available from: inamdarlegal.com. Accessed October 2026.
- CliniExperts. Bar code or QR code implementation on top 300 brands [G.S.R. 823(E), 17 November 2022; effective 1 August 2023]. Available from: cliniexperts.com. Accessed October 2026.
- RAPS. Asia-Pacific roundup: CDSCO advises drugmakers to only use pharma-grade excipients from approved sources [December 2023]. Available from: raps.org. Accessed October 2026.
This page is technical and educational information for pharmaceutical professionals. It is not legal, medical or investment advice. Indian statutory instruments, price-control orders and regulator positions change frequently; verify the current text and have a qualified advocate vet any agreement before signing.
