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Compliance Requirements under the Rules

1. Licence to sell, stock, exhibit or distribute drugs other than specified in Sch X (Rule 59 (2))

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.

2. Licence to sell, stock, exhibit or distribute drugs specified in Sch X (Rule 59 (2))

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.

3. Appeal against refusal of grant of licence under Form 20A or 21A (Rule 62B (2))

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.

4. Form 20: Licence for Drugs other than those specified in Schedules C, C(1) and X (Rule 61 (1))

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

5. Form 20A: Restricted Retail Licence for Drugs other than those specified in Schedules C, C(1) and X (Rule 61 (1))

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

6. Form 20B: Licence for Drugs other than those specified in Schedules C, C(1) and X by Wholesale (Rule 61 (1))

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

7. Form 21: Licence for Drugs specified in Schedules C, C(1) excluding those specified in Schedule X (Rule 62D)

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

8. Form 21A: Restricted Retail Licence for Drugs specified in Schedules C(1) excluding Schedule X (Rule 61 (3))

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

9. Form 21B: Licence for Drugs specified in Schedules C, C(1) excluding Schedule X by wholesale (Rule 61 (3))

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

10. Form 20F: Licence for Drugs specified in Schedule X by Retail (Rule 61 (2))

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

11. Form 20G: Licence for Drugs specified in Schedule X by Wholesale (Rule 62)

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.

12. Form 21BB: Licence to sell drugs by wholesale or distribute from motor vehicle listed in Sch C, C(I) (Rule 62D)

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

13. Form 20BB: Licence to sell drugs by wholesale or distribute from motor vehicle listed in Sch C, C(I) (Rule 62D)

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

14. Maintenance of Prescription register (Rule 65 (3) (1))

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.

15. Maintenance of Supply Records for Drugs (Retailer) (Rule 65 (4) (1))

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:

1. 1. A special register with these details: serial number, date of sale, buyer’s name and address, drug name and quantity, For Sch C drugs: manufacturer, batch number, expiry, signature of supervising seller; or
   2. A serially numbered cash or credit memo book containing the same details (except serial number of entry). 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

16. Maintenance of Purchase Records for Drugs by Retailer or Wholesaler (Rule 65 (4) (4))

(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

17. Maintenance of Supply Records for Drugs (Wholesaler) (Rule 65 (5) (1))

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:

1. 1. Date of sale
   2. Name, address, and licence number of the buyer (or details of the authority/institution/doctor if not a licensee)
   3. Drug name, quantity, and batch number
   4. Manufacturer’s name
   5. Signature of the authorised person supervising the sale Additionally, a carbon copy of the memo must be kept for 3 years from the sale date. 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

18. Condition for retail sale of Sch H, H1, and X Drugs (Rule 65 (9))

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.

19. Condition while dispensing drugs under Sch H, H1, and X Drugs (Rule 65 (11))

When dispensing drugs under Schedule H, H1, or X:

1. 1. The prescription can’t be used more than once unless specified.
   2. If the doctor mentions frequency, follow those instructions.
   3. Seller’s name, address, and the date of supply on the prescription, above the doctor’s signature.

20. Secure Storage of Schedule X Drugs in Retail Premises (Rule 65 (12))

Schedule X drugs kept in a retail shop must be stored securely:

1. 1. Either locked in a cupboard or drawer used only for them,
   2. Or in a separate area of the premises with access restricted to responsible persons only.

21. Display of Description Based on operations (Rule 65 (15))

Retailers must display appropriate descriptions

1. 1. Drugstore –No registered pharmacist required.
   2. Chemists and Druggists–Employ a registered pharmacist but don’t compound prescriptions.
   3. Pharmacy/Pharmacist/Dispensing Chemist-Employ a registered pharmacist and maintain a compounding setup.

    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.

23. Maintenance of Supply Records for Drugs under Sch X (Rule 65 (21))

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.

24. Separate Licence for Manufacturer of drugs at more than one place (Rule 68)

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.

25. Form 25B: Licence to repack drugs other than specified in Sch X, C and C(1) for sale (Rule 69 (1) (a) & 70)

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

26. Form 25F: Licence for manufacture drugs specified in Sch X (Rule 69 (1) (b) & 70)

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

27. Form 25: Licence to manufacture drugs other than specified in Sch X, C and C (1) (Rule 69 (1) (c) & 70)

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

28. Conditions to be complied for Licence in Form 25 or Form 25F (Rule 74)

Form 25/25F Licence Holders must comply with the following:

1. 1. Maintain staff, premises and equipment as specified in Rule 71
   2. Test each batch or lot of raw materials and maintain records for 5 years from the date of manufacture

      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.

1. 1. Repacking under supervision of approved competent person
   2. Adequate arrangements for tests and storage of drugs

      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

30. Conditions to be complied for Licence in Form 25A (Rule 74B)

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.

1. 1. Licence under Form 25 should not be cancelled or suspended
   2. Adequate arrangements for tests and storage of drugs

      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

31. Form 28A: Loan Licence to manufacture drugs specified in Sch C, C(1) excl. Sch X and Part XB (Rule 76A)

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

32. Form 28DA: Loan Licence to manufacture LVP, Sera and Vaccine and rDNA drugs specified in Part XB (Rule 76A)

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

33. Conditions to be complied for Licence in Form 28 / 28B / 28D (Rule 78)

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.

1. 1. Maintain staff, premises and equipment as specified in Rule 76
   2. Maintain manufacturing records as specified in Schedule U

      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.

1. 1. Maintain staff, premises and equipment as specified in Rules
   2. Maintain manufacturing records as specified in Schedule U

      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.

36. Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates (Rule 84B)

No persons shall manufacture for sale cyclamates and preparations containing cyclamates

37. Agreement for marketing (Rule 84D)

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.

38. Responsibility of marketer of the drugs (Rule 84E)

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.

39. Appeal against cancellation or suspension of Drug Manufacturing Licences (Rule 85)

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.