![Compliances under Drugs Rules, 1945 [Part VI, VII, VIII A]](https://1-comply.com/wp-content/uploads/2026/01/ChatGPT-Image-Jan-21-2026-03_55_10-PM-768x512.png)
Background
The Drugs Rules, 1945 were introduced under the Drugs and Cosmetics Act to standardize how medicines are manufactured, tested, and sold across India. They emerged during a period when the government sought stronger safeguards against unsafe or ineffective pharmaceuticals. The rules laid out scientific criteria for quality, labeling, storage, and distribution of medicinal products. By bringing regulatory clarity, they helped protect public health and support the growth of a structured pharmaceutical sector. Over time, amendments have kept the framework relevant as medical science and industry standards evolved.
Applicability
These Rules apply to:
Compliance Requirements under the Rules
An application for the grant of a licence to sell, stock, exhibit or offer for sale, or distribute drugs (other than those listed in Schedule X) shall be made in Form 19, along with a fee of ₹1,500, or in Form 19A, along with a fee of ₹500, as applicable. A fee of ₹150 shall be paid for the issuance of a duplicate copy of a licence to sell, stock, exhibit or offer for sale, or distribute drugs whether the drugs are included in Schedule X or not if the original licence is defaced, damaged, or lost.
For drugs included in Schedule X, the application shall be made in Form 19C, accompanied by a fee of ₹500, and submitted to the licensing authority. A fee of ₹150 shall be paid for the issuance of a duplicate copy of a licence to sell, stock, exhibit or offer for sale, or distribute drugs whether the drugs are included in Schedule X or not if the original licence is defaced, damaged, or lost.
Licence under Rule 62B(1) Application in form 20A, 21A is denied. The applicant has the right to appeal within 30 days, and the State Government will review the case and issue an appropriate order after giving an opportunity to be heard.
A licence to sell, stock, exhibit or offer for sale, or distribute drugs, other than those specified in Schedules C, C(1), and X, whether for retail under a restricted licence or for wholesale, shall be issued in Form 20, Form 20A, or Form 20B, as applicable. Before issuing licences in Forms 20, 20B, 20F, 20G, 21, or 21B, the licensing authority must ensure the site has suitable storage facilities and is managed by a person capable of overseeing drug handling. Form 20 or 21 licence for a pharmacy is granted only if Schedule N conditions are met
Renewal Period: Every 5 year
A licence to sell, stock, exhibit or offer for sale, or distribute drugs, other than those specified in Schedules C, C(1), and X, whether for retail under a restricted licence or for wholesale, shall be issued in Form 20, Form 20A, or Form 20B, as applicable. Restricted licences in Forms 20A and 21A shall be issued subject to the discretion of the licensing authority to dealers or persons in respect of drugs whose sale does not require the supervision of a qualified person.
Renewal Period: Every 5 year
A licence to sell, stock, exhibit or offer for sale, or distribute drugs, other than those specified in Schedules C, C(1), and X, whether for retail under a restricted licence or for wholesale, shall be issued in Form 20, Form 20A, or Form 20B, as applicable.
Renewal Period: Every 5 year
A licence shall be issued for sale by wholesale or for distribution from a motor vehicle of drugs other than those specified in Schedule C and Schedule C (1) in Form 20BB and of drugs specified in Schedule C and Schedule C (1) in Form 21BB. Provided that such a licence shall not be required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drugs
Renewal Period: Every 5 year
A licence to sell, stock, exhibit, offer for sale, or distribute drugs specified in Schedule X, whether by retail or wholesale, shall be issued in Form 20F or Form 20G, as the case may be. Form 20F is primarily for pharmacies but may be issued to a chemist and druggist in areas lacking pharmacy operations.
Renewal Period: Every 5 year
A licence to sell, stock, exhibit, offer for sale, or distribute drugs specified in Schedule X, whether by retail or wholesale, shall be issued in Form 20F or Form 20G, as the case may be.
Renewal Period: Every 5 year
A licence to sell, stock, exhibit, offer for sale, or distribute drugs listed in Schedules C and C(1) (excluding those in Schedule X) by retail under a restricted licence or by wholesale shall be issued in Form 21, Form 21A, or Form 21B, as applicable. Before issuing licences in Forms 20, 20B, 20F, 20G, 21, or 21B, the licensing authority must ensure the site has suitable storage facilities and is managed by a person capable of overseeing drug handling. Form 20 or 21 licence for a pharmacy is granted only if Schedule N conditions are met
Renewal Period: Every 5 year
If drugs are sold or stocked for sale at more than one place, separate application shall be made, and a separate licence shall be issued, in respect of each such place. Provided that this shall not apply to itinerant vendors who have no specified place of business and who will be licensed to conduct business in a particular area within the jurisdiction of the licensing authority.
A licence shall be issued for sale by wholesale or for distribution from a motor vehicle of drugs other than those specified in Schedule C and Schedule C (1) in Form 20BB and of drugs specified in Schedule C and Schedule C (1) in Form 21BB. Provided that such a licence shall not be required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drugs
Renewal Period: Every 5 year
A licence shall be issued for sale by wholesale or for distribution from a motor vehicle of drugs other than those specified in Schedule C and Schedule C (1) in Form 20BB and of drugs specified in Schedule C and Schedule C (1) in Form 21BB. Provided that such a licence shall not be required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drugs
Renewal Period: Every 5 year
If the drug is not compounded on-site and is supplied in the original container, the above details can be recorded in serially numbered cash/credit memo books maintained for this purpose. For repeat prescriptions, record only: new serial number, date of supply, quantity supplied, and a reference to the previous register entry. No register entry is required if: The supply is under the ESI Scheme and all particulars are on the prescription, or drug is not in Schedule C, H, or H1, supplied in an original unopened container, and the prescription is stamped with the supplier’s name and supply date, provided sub-rule 4(3) is followed. For Schedule H1 drugs, a separate register must be maintained with prescriber and patient details, drug name, and quantity. This register must be preserved for three years and made available for inspection.
If a drug listed in Schedule C is sold by retail (other than with prescription), the sale must be recorded at the time of supply in either:
(i) Records of purchase of a drug intended for sale or sold by retail shall be maintained by the licensee and such records shall show the following particulars, namely:—
(a) the date of purchase,
(b) the name and address of the person from whom purchased and the number of the relevant licence held by him,
(c) the name of the drug, the quantity and the batch number, and
(d) the name of the manufacturer of the drug.
(ii) Purchase bills including cash or credit memos shall be serially numbered by the licensee and maintained by him in a chronological order
Except where otherwise provided in these rules, all registers and records maintained under these rules shall be preserved for a period of not less than two years from the date of the last entry therein
Wholesale supply of drugs must be made using a cash or credit memo that includes the licensee’s name, address, and drug licence number. The memo must mention:
Schedule H, H1, and X drugs must be sold by retail only on a Registered Medical Practitioner’s prescription. For Schedule X, prescriptions must be in duplicate, with one copy retained for 2 years.
When dispensing drugs under Schedule H, H1, or X:
Schedule X drugs kept in a retail shop must be stored securely:
Retailers must display appropriate descriptions
22. Storage and Labelling of Veterinary Medicines in Retail Premises (Rule 65 (20))
Medicines meant for animal treatment must be clearly labelled as “Not for human use—for treatment of animals only” and stored either in a dedicated cupboard/drawer or in a separate area inaccessible to customers.
The supply of Schedule X drugs must be recorded at the time of supply in a bound, serially page-numbered register, with separate pages for each drug. The register must include the date of transaction, quantity received, supplier details (including licence number), name of the drug, quantity supplied, manufacturer’s name, batch or lot number, name and address of the patient or purchaser, prescription reference number, bill number and date, and the signature of the supervising person.
If drugs are manufactured on more than one set of premises a separate application shall be made and a separate licence shall be issued in respect of each such set of premises.
Application for grant of a licence to repack drugs (for sale or distribution), excluding those listed in Schedules X, C and C(1), shall be made in Form 24B Every application in Form 24B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees five hundred plus and an inspection fee of rupees two hundred for every inspection
Renewal Period: Every 5 year
Application for grant of a licence to manufacture drugs (for sale or distribution) listed in Schedules X shall be made in Form 24F. Every application in Form 24F shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every subsequent inspection
Renewal Period: Every 5 year
Application for grant of a licence to manufacture drugs (for sale or distribution) other than those listed in Sch X, C and C(1) shall be made in Form 24B Every application in Form 24 shall be made upto ten items for each category of drugs referred to in Schedule M relating to Pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection
Renewal Period: Every 5 year
Form 25/25F Licence Holders must comply with the following:
3. Maintain records of each batch of drugs manufactured and maintain records for 5 years from the date of manufacture
4.Maintain Inspection Book in Form 35
5. Maintain reference samples from each Batch of Drugs in quantity at least twice the quantity of drug required to conduct all test performed on the
batch
6.Maintain reference samples from each Batch of Drugs for a period atleast 3 months from the expiry date or 3 years from the manufacturing date if
expiry date not mentioned
7. A licensee granted licence in Form 25F shall:
8. Forward the statement of sales to the licensing authority of concerned state in every 3 months b. Maintain accounts of drugs specified in Schedule
X, production, for 5 years or 1 year after expiry of potency
29. Conditions to be complied for Licence in Form 25B (Rule 74A)
Form 25B licence holders for drug repacking must ensure supervision by an approved expert, test each batch, maintain records, allow inspections, store reference samples, and provide proper storage. Ads for Schedule H, H1, or X drugs need prior Central Government approval.
3. Allow inspection
4.Test each batch or lot of raw materials used for repacking and maintain records for 5 years from the date of repacking
5.Maintain Inspection Book in Form 35
6.Maintain reference samples from each Batch in quantity at least twice the quantity of the drug required to conduct the test performed on the batch.
7. Reference samples to be maintained for 3 months beyond the expiry of potency or 3 years from manufacturing date if expiry of potency not
mentioned.
8. No adv. except with the prior sanction of Central Government
Form 25A licence holders must test raw and finished products, retain records, maintain reference samples, allow inspections, and follow future rule changes. Licence gets cancelled if linked Form 25 licence is cancelled. Ads for certain drugs need approval. Bioequivalence data is required.
3. Allow inspection
4. Test each batch or lot of raw materials used for repacking and maintain records for 5 years from the date of repacking v. Maintain Inspection Book
in Form 35
5. Maintain reference samples from each Batch in quantity at least twice the quantity of the drug required to conduct the test performed on the
batch.
6. Reference samples to be maintained for 3 months beyond the expiry of potency or 3 years from manufacturing date if expiry of potency not
mentioned.
7. No adv. except with the prior sanction of Central Government
8. Submit the result of bioequivalence study referred to in Schedule Y
Loan licences for drugs under Sch C & C(1), excluding Sch X, LVPs, Sera, and r-DNA drugs, must be in Form 28A. Applicants must justify safety, efficacy, stability, and therapeutic purpose. In case of brand name, applicant would require Form 51 to be submitted to authority.
Renewal Period: Every 5 year
Loan Licence to manufacture LVP, Sera and Vaccine and rDNA drugs specified in Part XB must be in Form 28A. Applicants must justify safety, efficacy, stability, and therapeutic purpose. In case of brand name, applicant would require Form 51 to be submitted to authority.
Renewal Period: Every 5 year
Licences in Form 28, 28B, or 28D are subject to conditions under Schedules F/F1. Licensees must ensure adequate staff, testing, recordkeeping, proper storage, reporting of changes, batch-wise sampling, GMP/GLP compliance, and submission of bioequivalence data where applicable.
3. Allow inspection
4.Test each batch or lot of raw materials and finished products
5. Maintain test records for 2 years from the expiry of potency or 5 years from manufacturing date when expiry of potency is not mentioned
6.Maintain Inspection Book in Form 35
7. Maintain reference samples from each Batch in quantity at least twice the quantity of the drug required to conduct the test performed on the
batch.
8. Reference samples to be maintained for 3 months beyond the expiry of potency or 3 years from manufacturing date if expiry of potency not
mentioned.
9. No adv. except with the prior sanction of Central Government
34.Conditions to be complied for Licence in Form28A/ 28DA (Rule 78A)
Licences in Form 28A/28DA are subject to cancellation if linked licences are cancelled. Licensees must follow testing, recordkeeping, GMP/GLP standards, ensure proper lab access or tie-ups, retain samples, print expiry dates, maintain an Inspection Book, and submit bioequivalence data.
3. Allow inspection
4.Test each batch or lot of raw materials and finished products
5. Maintain test records for 2 years from the expiry of potency or 5 years from manufacturing date when expiry of potency is not mentioned
6. Maintain Inspection Book in Form 35
7. Maintain reference samples from each Batch in quantity at least twice the quantity of the drug required to conduct the test performed on the
batch.
8. Reference samples to be maintained for 3 months beyond the expiry of potency or 3 years from manufacturing date if expiry of potency not
mentioned.
9. No adv. except with the prior sanction of Central Government
35.Upload Manufacturing Licence Information on SUGAM Portal (Rule 84AB)
Every licensee issued a manufacturing licence under this Part is required to register on the SUGAM portal (www.cdscoonline.gov.in). They must upload relevant licence details in the prescribed format and ensure updates as needed. The concerned Licensing Authority will verify the uploaded information from time to time.
No persons shall manufacture for sale cyclamates and preparations containing cyclamates
No marketer shall adopt any drug manufactured by another manufacturer for marketing of such drug by labelling or affixing his name on the label of the drug with a view for its sale and distribution without an agreement as referred to in clause (ea) of rule 2.
Any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these rules.
The Central or State Licensing Authority can suspend or cancel a licence—wholly or partly—if the licensee violates the Act, Rules, or licence conditions. A written order with reasons must be issued after giving the licensee a chance to explain. The authority may also direct stopping of operations and destruction of stock in the presence of an Inspector. If aggrieved, the licensee can appeal within 90 days to the appropriate Government authority, which may confirm, reverse, or modify the order after hearing the case.
40. Restriction on place of import of drugs in India (Rule 43A)
Drugs shall be imported into India only through mentioned places which may be via road or air or railway or sea as:
a) import by air :Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa, Bengaluru and Visakhapatnam
b) import by sea :Designated ports at Chennai, Kolkata, Mumbai, Cochin and others as mentioned in the Rule
c) import by bv rail across the frontier with Pakistan : Firozepur Cantonment and Amritsar
d) import by bv rail across the frontier with Bangladesh : Ranaghat, Bongaon and Mohiassan
e) import by road from Bangladesh: Petrapole Road in West Bengal, Sutarkandi in Assam, old Raghna Bazar and Agartala in Tripura
f) import by road and railway lines connecting Raxaul in India and Birganj in Nepal: Raxaul
41. Particulars to mention on drugs bill by retail seller (Rule 65(4) (3))
Retail bill for a drug shall contain following particullars on it:
Carbon copies of cash or credit memos shall be maintained by the licensee as record.
42. Restriction on sale or stocking of drugs after its expiry (Rule 65(17)
Any drug shall not be sold or stocked by the licensee:
Exceptions: In case if licensee has taken steps with manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, may be stocked after the date of expiration of potency pending such withdrawal, reimbursement or disposal, as the case may be. All such drugs shall be kept in packages or cartons, the top of which shall display prominently, the words “Not for sale”
43. Restriction on sale or stocking of free samples of drugs (Rule 65(18))
Such Drugs shall not be sold/Stocked which are:
44. Procedure for disposal of drugs in the event of cancellation of licence (Rule 66A)
In case a licensee, whose license has been cancelled, desires to dispose of the drugs he has in his possession in the premises in respect of which tine licence has been cancelled, he shall apply in writing to the licensing authority and follow the prodecure as mention in the Rules
Licence shall apply in writing to the licensing authority for this purpose, giving following particulars:
(a) the name and address of the person to whom the drugs are proposed to be sold or supplied together with the number of the licence for sale or manufacture, as the case may be, held by him,
(b) the names of drugs together with their quantities, batch numbers, the names and addresses of their manufacturers and the dates of their expiry, if any, proposed to be sold to the person mentioned in clause (a).
45. Form 25A: Loan Licence for manufacture drugs other than specified in Sch X, C and C(1) (Rule 69A & 70A)
To apply for a loan licence (excluding drugs under Schedules C, C(1), and X), the applicant must use Form 24A, covering up to 10 items per category under Schedule M or M-III.
The licensing authority will grant the licence only after confirming that the manufacturing facility has adequate equipment, staff, and testing capabilities.
If applying for more than 10 items, an extra ₹300 per item is charged. If the loan licence is lost or damaged, a duplicate may be issued for a fee of ₹1,000
46. Form 28: Licence to manufacture drugs specified in Sch C and C(l) other than Part XB and Sch X (Rule 76)
A licence to manufacture for sale or for distribution of drugs specified in Schedules C and C(l) other than drugs specified in Part XB and Schedule X shall be issued in Form 28
47. Form 28B: Licence to manufacture drugs specified in Sch C and C(l) and Sch X (Rule 76)
A licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (l) and Schedule X shall be issued in Form 28B
48. Form 28D: Licence to manufacture LVP, Sera and Vaccine and rDNA derived drugs (Rule 76)
A licence to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs shall be issued in Form 28D
49. Re-application after rejection for Form 28/28B (Rule 82)
If a licence application is rejected, the applicant may reapply within six months by notifying the authority and paying ₹250 as inspection fee. Upon reinspection and satisfaction of compliance, a licence in Form 28 or 28B may be issued for drugs under Rule 68A.
When an application for a drug manufacturing licence is rejected, the applicant may reapply within six months by informing the Licensing Authority or Central Licence Approving Authority (as applicable) that the required conditions have been met. If the authority is satisfied upon conducting a fresh inspection that all prescribed conditions have been complied with—specifically for drugs notified under Rule 68A—it may issue the licence in Form 28 or Form 28B, depending on the case. This provision allows applicants a second opportunity within a limited timeframe to address deficiencies and obtain the required authorisation without having to undergo a completely new application process.
50. Appeal against refusal of drug licence under Part VII to State or Central Government (Ruke 84A)
If a drug licence under Part VII is refused, the applicant may appeal to the State or Central Government within 30 days of receiving the order. The authority will conduct necessary inquiry and provide a chance to be heard before passing a final order.
Any person who is aggrieved by the order passed by the licensing authority or the Central Licence Approving Authority, as the case may be, refusing to grant a licence under Part VII may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, and the State Government or the Central Government may, after such enquiry into the matter, as is considered necessary and after giving the said person an opportunity for representing his views, may pass such order in relation thereto as it thinks fit
51. License for Drug manufacturing for examination, test or analysis (Rule 89)
Whenever a drug is manufactured for the purpose of examination, test or analysis, and manufacturer does not possess license under form 25/Form28, he shall obtain license in form 29
In case if drug composition is such that the drug is not generally recognised among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for us then no licence in Form 29 shall be granted unless the applicant produces a certificate from the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 102 of 963 licensing authority mentioned in rule 21
Penalty & Punishment
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