Drugs and Cosmetics

Act
PART IV
Manufacture of drugs- provisions
governing
 Types of licences
 Manufacturing
 Loan and licence manufacturing
 Repacking licence
 Conditions for grant of licence
 Conditions to be complied after grant of licence
 Additional conditions for Sch X drugs
 Accounts of drugs used for manufacture, production, manufactured drug
Provisions governing Manufacture of Drugs

Licence for Manufacture of Drugs

Loan Licences (other than Schedule X drugs)

Repacking Licences
Prohibition of Manufacture and Sale of Certain
Drugs
 Not of Standard Quality
 Patent or Proprietary medicine whose formula not disclosed on the label
 Drug that claims to prevent or cure any disease specified in Schedule J
 Any drug in contravention of this Act or Rules
 Imported or manufactured in contravention of provisions of the Act or Rules
Types Class Forms
Application Grant of Licence Renewal ceritificate

Manufacture of a. Drugs other than 24 25 26

Drugs those in Schedule C, C1
and X

b. Drugs specified in 24-F 25-F 26-F

Schedule X
c. Drugs specified in 27 28 26
Schedule C, C1
excluding Schedule X

d. Specified in C, C1 27 28 26
and X
e. Operation of Blood 27-C 28-C 26-G
Bank, Processing of
Blood components, Mfr
of Blood Products
Types Class Forms
Application Grant of Licence Renewal ceritificate

Loan Licences Other than C, C-1 and 24-A 25-A 26-A

X drugs

Drugs specified in C, 27-A 28-A

C1
Repacking Other than C, C1 and X 24-B 25-B 26-B
Licence drugs only
Conditions for Licence
For grant
• Competent technical staff
• Premises, plant, equipment comply with
Schedule M
• Testing unit and equipment for QC
• Storage arrangements
• Patent or proprietary medicines- evidence
or data justifying the same
After grant of Licence
• Adequate staff, premises and equipment
• Comply with provisions of the Act
• Adequate testing facilities
• Maintain records as per Schedule U
• Allow Inspector to enter and inspect, take
samples
• Report any changes in expert staff
• Supply samples for test
• On order of LA, NOT sell any batch or part
of it
• Withdraw any batch or part of it if directed
by LA
• Maintain Inspection book
• Reference samples to be maintained
 Further for Schedule X
 Accounts of drugs specified in Schedule X in a register bound and serially page
numbered
 Including accounts of production
 Manufactured drugs
 Supply and Sale of Drugs
Manufacture…..

Drugs for Examination, Test or Manufacture of New Drugs

Analysis
- Licence in Form 29 (No objection - Prior approval of LA
certificate from central LA for Drug - Schedule Y applies for clinical trials
not recognised as safe for use) and for manufacture of new drugs

Conditions: - Documentary and other evidence

- To be used exclusively for the relating to standards of quality, purity,
purpose specified safety and other information to be
- Allow inspection provided
- Record of quantity manufactured
- Maintain inspection book
- Comply with any Rules made
subsequently (on a month’s notice)
Provisions governing Sale of Drugs

Retail

Types of
Licence
Wholesale Restricted
Licences for Sale

FORM Nos Other than Sch Sch C, C1 Sch X

C, C1 and X
RETAIL 20 21 20-F

RESTRICTED 20-A 21-A NOT ISSUED

WHOLESALE 20-B 21-B 20-G

Conditions for Licence
To issue
• Premises adequate and equipped
• For restricted- number of licences in the area
• ‘Pharmacy’- Schedule N to be complied with
• For wholesale- Not less than 10 sqm;
• In charge of a registered pharmacist
After issue
• Display licence in prominent place
• Comply with provisions
• Purchase and sell under cash or credit
memo
• Any change in constitution of the firm
to be notified to LA
• Restricted licence (21A)- only those
drugs that do not require supervision by
Regd Pharmacist
• Wholesaler not to sell to person not
holding a licence except to person on
behalf of Govt., hospital, medical or
research institution, physician
• Compounded and dispensed under
supervision of a registered pharmacist
Conditions for Licence (Sale)

 Dispensing and Compounding of Drugs:

 Compounded only under the personal supervision of Registered
Pharmacist
 Dispensed under the supervision of Regd Pharmacist
 Supply of all drugs INCLUDING C AND C(1) to be recorded in a
prescription register with all details including Date, Name and address
of prescriber, Name of the drug, Mfrr., Mfg date, Batch no and
signature of the pharmacist
(CASH MEMO BOOK FOR DRUGS SUPPLIED FROM ORIGINAL
CONTAINERS)
 Sale of Schedule H and X drugs
 Only on prescription of a RMP
 Sch X drugs- prescription duplicate copy to be retained
 Quantity specified by prescriber dispensed only once
 Schedule X drugs- under lock and key
 Records of Purchase
 Wholesaler to maintain records of supply
 Produce all records and registers for inspection
 Inspection book: Form 35 to be maintained
 Not to sell drugs that have crossed expiry date
 Stock with labels ‘ Physician’s sample, Not for Sale’, ‘CGHS’, ‘ESIC’, ‘AFM stores’
not to be sold
 Drugs for veterinary use to be stored separately
 Records of supply of Schedule X drugs to be maintained
Prohibition of Sale

 Any drug not of standard quality, misbranded, adulterated or spurious

 Any patent or proprietary medicine not displaying true formula on the label
 Claiming cure for disease given in schedule J
 Contravening provisions under the Act
Import of drugs: provisions

 Classes of drugs that are prohibited from import

 Classes of drugs that can be imported under licence or permit
 Classes of drugs that can be imported without licence
 Conditions of licence
 Methods of registration, licence application
 Prohibition of Import
• Drug or Cosmetic not of standard
quality (Misbranded, Adulterated or
Spurious)
• Without a licence
• Not labelled and packed in
prescribed manner
• Drug claiming to cure or prevent any
disease specified in Schedule J
• Drugs prohibited in its country of
origin
Classes that can be imported
• Drugs other than Schedule C, C1 and
X
• Drugs specified in Schedule C, C1
excluding Schedule X
• Drugs specified in Schedule X
• Small quantities for purpose of
examination, test or analysis (Form
11)
• By Govt hospital/autonomous
medical institution for treatment of
patients
• For personal use covered by a
prescription of RMP
• Any new drug
Provisions governing Import of Drugs- Flow chart

Application for Registration

Licence
Licence Certificate
• Form 8 • Form 10 • Application in
• Form 8A (Schedule • Form 10A Form 40
X drugs) (Schedule X drugs) • RC issued in Form
41
• D-I and D-II
information and
undertakings to be
given
 Application
• Licence fee of Rs. 1000, Rs.
100 for every additional drug
• Undertaking in Form 9
Registration Certificate
• Fees US $1500 for premises
and US $1000 for drug
• US $ 300 for duplicate
certificate
• US $5000 for inspection or
visit to manufacturing
premises
• NOT for INACTIVE BULK
SUBSTANCE
Conditions to be satisfied
Before grant of licence
• Premises- proper storage and
accommodation for drugs
• Occupation, trade or business
ordinarily carried out by the
applicant (should not be convicted
under NDPS Act or non-
compliance with provisions under
the Act)
• Person aggrieved by the order of
LA may appeal within thirty days
to Central Government.
For Licence (After grant)
• Observe undertaking given in
Form-9
• Allow Inspector to enter and
inspect
• Furnish any sample required for
analysis to LA
• If LA directs- shall not sell any
batch
• Withdraw any batch or part of a
batch if directed to do so
• Maintain a record of all sales;
separate record of Schedule X
drugs
Packing of drugs
 As per provisions given in Schedule P-1

 Tablets/Capsules: < 10- integral number, > 10: multiples of 5

 Liquid orals: 30ml (paediatric) 60ml/100ml/200/450ml

 Paediatric oral drops: 5ml/10ml/15ml

 Eye/Nasal/Ear drops: 3ml/5ml/10ml

 Ointment: 3gm/5gm/10gm

 Does not apply to imported finished products, physician’s samples,

hospital supplies etc
Schedule X drugs: packing

 Tablets/Capsules: Not more than 100 unit doses for retail sale
 Liquid orals: Not more than 300ml
 Injections: not more than 5ml
Provisions governing Cosmetics

 Prohibition of certain cosmetics

 Manufacture of Cosmetics

 Sale of Cosmetics

 Labelling and Packing of Cosmetics

Prohibition of Import/MFR of Cosmetics

 Not of Standard Quality- Misbranded/Spurious/Adulterated

 Cosmetics containing Hexachlorophene
 Coal tar colour other than one prescribed
 Cosmetics containing more than 2ppm or arsenic or 20ppm lead or 100ppm of
any other heavy metal
 Containing mercury compounds
Manufacture of cosmetics

Application Licence
Form no 31 Form no 32
Form 31A for Loan Licence Form 32A for Loan Licence
 Licence is required
 Conditions for Issue:
 Competent technical staff
 Comply with Schedule M II
 Adequate facilities for testing
 Conditions after Issue:
 Staff, Premises
 Records as per U(1)
 Conditions for Licence:
 Test each batch of RM and FP
 Allow Inspection
 Inspection Book in Form 35
 Cancellation and Suspension of Licence
 Sale of Cosmetics
Labelling and Packing of Cosmetics

 Name of the Cosmetic

 Name and Address of the manufacturer
 Proper direction of safe use, Warning, Special directions
 Batch No
 Month and Year of manufacture
 Fluoride toothpaste: Content of fluoride and Date of expiry
 Special Labelling of Hair Dyes containing Coal Tar colours
 This product contains ingredients which may cause skin irritation in certain cases and
so a preliminary test according to the accompanying directions should be made. This
product should not be used for dyeing eye-lashes and eye-brows as such use may cause
blindness.
Manufacture of A/S/U drugs

Manufacture Loan Licence

Application 24-D 24-E
Licence issued 25-D 25-E

 Licence is required for manufacture

 Conditions for grant/renewal of licence:
 Comply with Schedule T
 Competent technical staff: qualified in respective discipline
 Conditions for licence:
 Maintenance of proper records
 Allow Inspection
 Maintain Inspection book
Provisions: Ayurvedic/Siddha/Unani
drugs
 Ayurvedic (including Siddha) and Unani DTAB (ASUDTAB)
 ASUDCC
 Government Analyst
 Inspectors
Labelling and Packing of A/S/U Drugs
 List of all ingredients
 Substance from Schedule E(1): Caution
 Name, Net content
 Name and Address of Mfrr
 Batch No or Lot No
 Date of Mfr
 The words ‘ Ayurvedic medicine, Siddha medicine or Unani
Medicine’
 For External Use Only for external use preparations
 Packing of Asavas with high concentration of alcohol
 15ml max
Containing self generated alcohol (16% v/v)-
Mritasanjivani Sura- 30 ml
Mahadrakshasav- 120 ml
 Sale of A/S/U drugs: No licence required
 Prohibition of Manufacture/Sale of:
 Adulterated/Spurious/Misbranded
 Patent or proprietary medicine without true list of ingredients
 Any product manufactured in contravention of any provisions of the Act or Rules
 Offences and Penalties
Labelling and packing of A/S/U drugs

 Label should contain following particulars:

 True list of ingredients
 Caution in case of poisonous substance (as listed in Sch E1)
 Name of the drug as per literature in First Schedule
 Other details
 Pack size: Not more than 15 ml for high alcohol content preparations.
Provisions applicable to homoeopathic
medicines
 Import: No licence required. Only for new homoeopathic
medicine.
 Manufacture:
 Homoeopathic mother tincture and potentised preparations
 Potentised preparations only
 Potentised preparations from back potencies by pharmacies which are
licenced.

Form No Manufacture
Application 24-C
Licence issued 25-C
 Licence is required for manufacturing
 Conditions for Mfg Licence
 Schedule M(I) compliance
 Competent technical staff
 Distinct premises

 Sale: Licence required; No records required be maintained (upto

60ml)

Form No Sale
Application 19-E
Licence issued 20-C Retail
20-D Wholesale
 Labelling:
 “Homoeopathic medicine”
 Name of the medicine
 Potency in decimal/centesimal/millisimal
 Name of each ingredient
 % of alcohol
 Batch or Lot Number
 Manufacturing Licence
 Proprietary name, if so.