Drugs & Cosmetics Act 1940

&
Rules 1945

Dr. Ravindra Purohit

M.Pharm., Ph.D.
History
 POSITION TILL 1930 : India was largely dependent on import of modern
medicines until after first word war.

In August 1930 the government of India appointed a drug Enquiry Committee

under the chairmanship of colonel R.N. Chopra, to go in to the question of
adulterated & substandard drugs sold in country & to recommend step by
which this menace could be control.

The Drug Enquiry Committee submitted its report in 1931,the government of India
could not give effect to its recommendation till 1937.

After passing of the government of India Act,1935, drug became provincial

subject & therefore center could pass law in respect of only imports.

The drug import Bill was prepared & placed for consideration before the
assembly in 1939. This was not acceptable to the public & provinces for uniform
& comprehensive legislation. This led to the introduction of the Indian Drug Bill in
the Central Legislature. It was passed & became Drug Act in 1940.
LIST OF AMENDING ACTS AND ADAPTATION ORDER

1. The Repealing and Amending Act, 1949 (40 of 1949).

2. The Adaptation of Laws Order, 1950.

3. The Part B States (Laws) Act, 1951 (3 of 1951)

4. The Drugs (Amendment) Act, 1955 (11 of 1955)

5. The Drugs (Amendment) Act, 1960 (35 of 1960)

6. The Drugs (Amendment) Act, 1962 (21 of 1962)

7. The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964)

8. The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972).

9. The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982)

10. The Drugs and Cosmetics (Amendment) Act, 1986 (71 of 1986)

11. The Drugs and Cosmetics (Amendment) Act, 1995 (22 of 1995)

12. The Drugs and cosmetics (Amendment) Act, 2008

 INDIAN DRUG LEGISLATION
Objective
The Objective of Drugs & Cosmetics Act 1940 is to ensure that
public are supplied with Quality, Purity, Identity, Safety and
efficacy of Pharmaceutical Products & Cosmetics.

Basic Philosophy
The basic philosophy of Drugs & Cosmetics Act is that
The manufacturer is responsible for the quality of drugs
manufactured by them.
The Government/Regulatory Agencies will monitor the quality
of drugs by periodic inspections of the manufacturing and sales
premises for confirmation to the provisions of Drugs &
Cosmetics Act.
Monitor the quality of drugs moving in the market by carrying
out post market surveillance.
 INDIAN DRUG LEGISLATION Contd.
Principle
The principle on which the Drugs & Cosmetics Act function is by a
system of licensing under which all the activities involved in
manufacture, sale and distribution of Drugs & Cosmetics are
controlled.

Drug regulatory system in India

Drug is in concurrent list of Indian Constitution. It is governed by both
Centre and State Governments under the Drugs & Cosmetics Act 1940
& Rules 1945 there under.
 Part I : DRUG & COSMETIC ACT, 1940
CHAPTER I :
INTRODUCTORY

CHAPTER II : THE DRUGS TECHNICAL ADVISORY

BOARD, THE CENTRAL DRUG LABORATORY, THE
DRUGS CONSULTATIVE COMMITTEE

CHAPTER III : IMPORT OF

DRUGS AND COSMETICS

CHAPTER IV : MANUFACTURE, SALE

AND DISTRIBUTION OF DRUGS AND
COSMETICS

CHAPTER IV-A : PROVISIONS

RELATING TO AYURVEDIC,
SIDDHA AND UNANI DRUGS
CHAPTER V: MISCELLANEOUS
 Part II: DRUG & COSMETIC RULES, 1945

PART I : PRELIMINARY

PART II : THE CENTRAL DRUGS LABORATORY

PART III (Rules 9 to 20)

PART IV : IMPORT [AND REGISTERATION]

PART V: GOVERNMENT ANALYSTS, INSPECTORS, LICENCING AUTHORITIES AND

CONTROLLING AUTHORITIES

PART VI : SALE OF DRUGS OTHER THAN HOMOEOPATHIC MEDICINES

PART VI-A : SALE OF HOMEOPATHIC MEDICINES

PART VII : MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF DRUGS OTHER

THAN HOMOEOPATIC MEDICINES
PART VIII : MANUFACTURE FOR EXAMINATION, TEST OR ANALYSIS

PART IX : LABELLING AND PACKING OF DRUGS OTHER THAN HOMOEOPATHIC

MEDICINES

PART X : SPECIAL PROVISIONS RELATING TO BIOLOGICAL ANDOTHER SPECIAL

PRODUCTS

PART XA : IMPORT OF MANUFACTURE OF NEW DRUG FOR CLINICAL TRIALS OR

MARKETING

PART XB : REQUIREMENTS FOR THE COLLECTION, STORAGE,PROCESSING AND

DISTRIBUTION OF WHOLE HUMAN BLOOD, HUMAN BLOOD COMPONENTS BY
BLOOD BANKS AND MANUFACTURE OF BLOOD PRODUCTS
PART XI : EXEMPTIONS

PART XII : STANDARDS

PART XIII : IMPORT OF COSMETICS

PART XIV : MANUFACTURE OF COSMETIC FOR SALE OR FOR DISTRIBUTION

PART XV : LABELLING, PACKING AND STANDARDS OF COSMETICS

PART XV : MANUFACTURE FORSALE OF AYURVEDIC (INCLUDING SIDDHA) OR

UNANI DRUGS
PART XVII : LABELLING, PACKING AND LIMIT OF ALCOHOL
IN] AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS

PART XVIII-GOVERNMENT ANALYSIS AND INSPECTORS

FOR AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS

PART XIX : STANDARDS OF AYURVEDIC, SIDDHA AND

UNANI DRUGS
 SCHEDULES TO D&C ACT1940

First schedule Names of books under Ayurvedic and

Siddha systems

Second schedule Standard to be complied with by imported

drugs and by drugs manufactured for sale, sold, stocked or
exhibited for sale or distribution
 SCHEDULES TO D&C RULES 1945
Type Content

A Performa For Forms ( Application, Issue, Renewal, Etc.)

B Rates Of Fee For Test Or Analysis By CDL Or Govt. Analysts

C List Of Biological And Special Products (Injectable) Applicable To

Special Provisions.

C1 List Of Biological And Special Products (Non-parenteral) Applicable To

Special Provisions.

D List Of Drugs That Are Exempted From Provisions Of Import

E1 List Of Poisonous Substances Under The Ayurvedic , Siddha And Unani

Systems

F Provisions Applicable To Blood Bank

 SCHEDULES TO D&C RULES 1945
Type Content

F1 Special Provision Applicable To Biological And Special Products, Eg.

Bacterial And Viral Vaccines, Sera From Living Animals, Bacterial
Origin Diagnostic Agents

F2 Standards For Surgical Dressings

F3 Standards For Umbilical Tapes

Ff Standards For Ophthalmic Preparations

G List Of Substances Required To Be Used Under Medical Supervision

And Labelled Accordingly

H List Of Substances (Prescription) That Should Be Sold By Retail

Only On Prescriptions Of R.M.P.
 SCHEDULES TO D&C RULES 1945
Type Content
J List Of Diseases And Ailments That Drug Should Not Claim To Cure
K List Of Drugs That Are Exempted From Certain Provisions
Regarding Manufacture

M Requirements Of Manufacturing Premises, GMP Requirements Of

Factory Premises, Plants And Equipments
M1 Requirements Of Factory Premises For Manufacture Of Homeopathic
Medicines
M2 Requirements Of Factory Premises For Manufacture Of Cosmetics
M3 Requirements Of Factory Premises For Manufacture Of Medical
Devices
N List Of Equipment To Run A Pharmacy
O Standards For Disinfectant Fluids
 SCHEDULES TO D&C RULES 1945
Type Content
P Life Period(expiry) Of Drugs
Q Coal Tar Colors Permitted To Be Used In Cosmetics
R Standards For Mechanical Contraceptives
R1 Standards For Medical Devices
S Standards For Cosmetics
T Requirements (GMP) Of Factory Premises For Ayurvedic, Siddha,
Unani Drugs
U Manufacturing And Analytical Records Of Drugs
U1 Manufacturing And Analytical Records Of Cosmetics
V Standards For Patent Or Proprietary Medicines
W List Of Drugs Marketed Under Generic Names- Omitted
X List Of Narcotic Drugs And Psychotropic Substances
Y Requirement And Guidelines On Clinical Trials For Import And
Manufacture Of New Drugs
Good Laboratory Practices (GLP)
Schedule L-I
 IMPLIMENTATION OF SCHEDULE L-I
The draft GLP published dated 13th October 2006 inviting
objections & suggestions from Stake holders.
Objections and suggestions received from the public on the
said draft rules were considered by Govt. of India.
Thereafter, in exercise of the powers conferred by the sections
12 & 33 of D & C Act, the Central Government after
consultation with the DTAB, made the rules called as D & C
(3rd amendment) Rules 2008.
The Drugs and Cosmetics Rules were amended to
incorporate Schedule L-I on GLP and Requirement of
premises and equipments published under notification GSR
780 (E) dated 10th November 2008
(File No. X-11014/3/2006-DFQC).
 IMPLIMENTATION OF SCHEDULE L-I contd.
A period of two years was granted for the Pharma industry to make
necessary arrangement to comply with the requirement of Sch. L-I
before these are made mandatory.
Accordingly the notification mentioned that these Rules will be
effective from first day of November, 2010.
The labs are required to comply all the GLP norms mentioned in
the Schedule L-I of D & C Act a per Rule 74, 78 & 150-E to cover
quality system/SOPs, equipment calibration/validation, reference
materials, reagents, staff, testing procedures, results record &
computerization, personnel & environmental safety, data integrity,
including archiving.
Internal quality system audits are required to put in practice to
verify that the operations conduct in the laboratories comply with
the requirements of quality system.
State licensing authorities may ensure that the provisions under Sch.
L-I are implemented in the testing laboratories set up by the
manufacturers for in house testing and approved testing
laboratories.
 DEFINITION OF GLP
Good Laboratory Practice (GLP) deals with the organization,
process and conditions under which laboratory studies are planned,
performed, monitored, recorded, reported & archived. GLP
practices are intended to promote the quality and validity of test
data (part 58 CFR 21). OR
GLP is a quality system concerned with the organizational process
and the conditions under which non clinical health & environmental
safety studies are planned, performed, monitored, recorded,
archived & reported. (Ref. Jurg P. Seiler-Switzerland, GLP, 2nd
edition by Springer publication, 2005, Page 61).
Schedule L-I regulations and guidelines have a significant impact on
the daily operation of an analytical laboratory.
GLP is a regulation. It is not only good analytical practice. Good
analytical practice is important, but it is not enough. For example,
the laboratory must have a specific organizational structure and
procedures to perform and document laboratory work. The
objective is not only quality of data but also traceability and
integrity of data. But the biggest difference between GLP and Non-
GLP work is the type and amount of documentation.
 ROLE OF GLP INSPECTORS
For a FDA/CDSCO inspector it should be possible to look at
the documentation and to easily find out
who has done a drug sample testing,
how the sample testing was carried out,-
which procedures have been used, and
whether there has been any problem and if so
how it has been solved.
The FDA inspectors should look at the possibility for a third
party to reconstruct the whole drug samples testing plan &
second issue can be looked at as accountability for mistakes of
above plan & thirdly GLP increases awareness for quality and
transparency of the analysis of different samples conducted at
their laboratory.
GLP Compliance as per Schedule L-I of Drugs & Cosmetics
Act.
 ROLE OF GLP INSPECTORS Cont..

Basic research, Disease Discovery & Drug Discovery are not

regulated for GLP.
The GLP regulation starts from Pre-clinical development to
QC Laboratories.
Clinical trials are regulated by good clinical practice
regulations and manufacturing through GMPs.
Characteristic for GLPs is that they are study based where as
GMPs are processed based
 ELEMENTS OF GLP

To a large range of laboratory related issues that can shortly

be characterized as follows:

1- Laboratory infrastructure and personnel.

2- Laboratory methodologies & reference values.
3- Laboratory equipment & maintenance.
4- Test result records & computerization.
5- Quality system (internal audits, management review).
6- Function of annual units and experiments.
7- SOPs & General safety.
8- Storage and archival.
 ORGANIZATION & MANAGEMENT
The laboratory or the organization of which it is a part must be
an entity that is legally authorized to function & can be held
legally responsible.
It is the responsibility of the management to ensure that the
laboratory carry out its testing, calibration, validation & all other
technical activities in such a way as to meet GLP requirements as
per Schedule L-I
The laboratory should be organized and operate so as to meet
the requirements of Schedule L-I.
The laboratory should have a qualified individual to be known
as quality manager or technical manager with the authority and
resources needed for carrying out all technical activities and for
the implementation of documented quality system to report
directly to top management.
The quality manager shall prepare a Schedule for technical audit
of lab for GLP compliance as per quality manual.
 PREMISES
The laboratory facilities shall be designed, constructed and
maintained so as to prevent entry of insects and rodents besides
cross contamination.
The lab interior surface (walls, floor and ceilings) should be smooth
and free from cracks and permit easy cleaning/disinfection.
Adequate area should be provided for equipments for carrying out
different tests but also for utilities like water, gas and power.
The lab should have air ventilation system to ensure dust free
environment.
The lab should be provided with adequate lighting and ventilation
and if necessary AC to maintain proper temperature/RH that will
not effect the testing and storage of drugs or accuracy functioning of
equipments.
The lab should have proper drainage system to avoid water logging.
Tabletops shall be constructed with acid, alkali and solvent resistant
material (Free from crevices).
 PREMISES Cont..
All the laboratory waste material generated, before, during &
after testing of different pharmaceutical products/cosmetics
should be destroyed as per Bio-Medical waste rules 1996
(management & handling).
The laboratory should ensure that environmental conditions
are monitored, controlled & documented.
Adequate area should be provided for storage of reference,
working standards & thereof specific SOP should be prepared
by the laboratory.
If the laboratory engaged with microbiological testing, BET
testing & sterility testing should meet the requirements of air
circulation (HVAC system) with requisite class condition as
per the revised Schedule M of D & C Act 1940.
The bio burden levels should be routinely monitored in the
airlocks provided for controlled & un-controlled areas.
 PREMISES Cont..
The Lab should have proper area for animal house and
should have the approval of the Committee for the Purpose of
Control and Supervision on Experiments on Animals
(CPCSEA) from regional office of ethics animal committee.
The lab should have proper segregation for quarantine the
new animals procured are purchase and have a provision for
clean corridor and dirty corridor.
The disease animals shall be properly diagnosed with proper
record of their treatment.
Different types of animals should be housed separately with
proper identification.
The Lab should have air conditioner (AC) for animal house
(Temp./RH).
The Animal house should be isolated from the laboratory
with separate entrance if applicable.
 PERSONNEL
The laboratory should have sufficient staff with necessary
qualification, training, experience for their assigned functions
and thereof training records are maintained.
The head of the laboratory must be off high professional
standing with experience for testing of drug samples & lab
management is responsible for ensuring control and
maintenance of documents including quality system.
The laboratory should have proper planning and organizing the
audit of quality system to take care of CAPA.
CAPA resulting from the investigation of complaints, product
rejections, non conformances, recalls, deviations, audits,
regulatory inspections & findings, trends from process
performance & product quality monitoring. The objective of
CAPA is determining the root cause of deviation.
Corrective Action: Action to eliminate the cause of a detectable
non-conformity or other undesirable situation. Note: Corrective
action is taken to prevent recurrence whereas preventive action
is taken to prevent occurrence (ISO 9000:2005)
 PERSONNEL cont

Preventive Action: Action to eliminate the cause of potential

non-conformity or other undesirable potential situation.
Note: Preventive action is taken to prevent occurrence
whereas corrective action is taken to prevent recurrence (ISO
9000:2005).
The laboratory should have proper planning for investigation
of technical complaints including NSQ reports for regulatory
action.
 EQUIPMENT

The laboratory should have the required equipments for

carrying out the different activities within the lab.
The analytical instruments should be kept in dust free
environment with proper control of temperature and
humidity.
The equipment should be kept under hygienic conditions and
tidy (logical/orderly/arranged/uncluttered) at all times.
The laboratory should have proper calibration plan and
validation plan for equipments provided to carry out at
specified regular intervals and records of such
calibration/validation reports be maintained.
 EQUIPMENT cont...
The records should be maintained for all the equipments consisting of:
I. Name of Equipment or Machine or Apparatus;
II. Manufacturers name, Model number and type of identification;
III. Serial number;
IV. Date on which equipment was received in laboratory;
V. Current location;
VI. Condition when received (e.g. new, used, re-conditioned)
VII. Copy of the manufacturers operating instructions;
VIII. Frequency of calibration;
IX. Frequency of maintenance;
X. Log Book (Day to day entry including status of the equipment)
XI. Staff responsible for monitoring the calibration and maintenance status of the
equipment;
XII. Calibrating records;
XIII. List of authorized users or operators, if any;
XIV. History of any damage, malfunction, modification or up gradation, repair and
calibration;
XV. List of spares and accessories, if any;
 EQUIPMENT cont...

The laboratory should have separate register for defective

equipments and also spare/accessories.
The lab. should have respective SOPs for operation, performance,
calibration & maintenance of equipments.
The lab. should have thorough checks for accuracy of important
items like; burettes, pipettes, volumetric flasks, weight boxes,
thermometers, etc., before use.
The lab. Should have competent person for handling and
maintenance of equipments for services like; electricity, gas, water,
steam and compressed air, etc.
The lab. should have well defined area for handling of hazardous
solvents, reagents and chemicals with proper exhaust system and
drainage system to avoid water logging inside the fume cupboard.
The lab. Should have proper log books, calibration chart reports,
validation reports, engineering requisition slips for
repair/modification if any, CAPA system, change management
system and equipments service records.
 CHEMICALS & REAGENTS

The laboratory should have proper plan for storage and

handling of chemicals and reagents while preparing by taken
into the consideration of Physico-chemical properties with
proper status label.
Register should be maintained for standardization of stock
solutions, standard solutions & volumetric solutions etc.
All the above said chemicals/ reagents should be off appropriate
quality if required the Lab head must insist the COA, MSDS &
reputation of suppliers in the market for their quality standards.
The labeling should be appropriate to meet the parameters like
concentration, strength, storage condition, date of preparation,
use before, standardization factor, sign of chemist etc.
Visual inspection is carried out for reagents if applicable.
Water should be considered as a reagent & appropriate water
grade for specific test should be used as described in the various
Pharmacopoeias or in approved tests when available.
 GOOD HOUSE KEEPING & SAFETY
Lab should prepare adequate poster displays, audio visual
material, & conduct seminars and conferences for safety aspects.
Safety Data sheets must be available before testing is carried out.
Drinking, eating, smoking shall not be permitted in lab.
Laboratory staff must wear protective clothing including gloves,
facemasks & eye protection when ever required.
Lab should be equipped with adequate number of fire
extinguishers, fire blankets and gas masks etc. and also first aid
kit.
Adequate training is must for staff for handling of safety
equipments (emergency care and use of antidotes, handling
cylinders of compressed gases).
Lab should have well defined SOP for safety, housekeeping,
training, disposal of wastes (chemicals and biological), handling
of corrosive materials (Hg, KCN, CNBr), infectious agents,
mixing of water with Acids etc.
MAINTENANCE, CALIBRATION & VALIDATION OF EQUIPMENT

Maintenance: A procedure of inspecting, testing, and reconditioning a

system at regular intervals according to specific instructions, intended to
prevent failures in service or to retard deterioration.
Calibration: The process of determining the performance parameters of
an artifact (object) , instrument, or system by comparing it with
measurement standards (Accuracy & Precision).
Validation: Action of proving and documenting that any process,
procedure or method actually and consistently leads to the expected
results.
Validation vs. Qualification: The term qualification is normally used for
equipment, utilities and systems, validation is normally used for
processes in this sense, qualification is the part of validation.
Validation should be performed for new premises, equipments, utilities,
systems, procedures & processes at periodic intervals & when major
changes have been made.
Risk assessment approach should be used to determine the scope &
extent of validation required.
MAINTENANCE, CALIBRATION & VALIDATION OF EQUIPMENT

Qualification: Action of proving & documenting that any

analytical equipment complies with the required
specifications and performs suitably for its intended purpose.
The lab should have well defined SOP, qualification protocols,
calibration schedule, appropriate methods and procedures for
all tests or calibrations.
The lab should have records for calibration of equipments and
other required documents including log books.
 QUALITY MANAGEMENT SYSTEM

QMS: An appropriate infrastructure, encompassing the

organizational structure, procedures, processes and resources,
and systematic actions necessary to ensure adequate
confidence that a product or service will satisfy given
requirements for quality.
Quality System: Aggregate of the organizational activities,
incentives, plans, policies, procedures, processes, resources,
responsibilities, and the infrastructure required in
formulating and implementing a total quality management
(TQM) approach in a testing laboratory.
Quality Manual: A handbook that describes the various
elements of the quality management system for assuring the
quality of the test results generated by a laboratory.
 REFERENCE MATERIAL
Reference material: Material sufficiently homogeneous and stable
with respect to one or more specified properties, which has been
established to be fit for its intended use in a measurement processes .
Reference substance (or standard):An authenticated, uniform
material that is intended for use in specified chemical and physical
tests, in which its properties are compared with those of the product
under examination, and which possess a degree of purity adequate
for its intended use .
Primary reference substance (or standard): A substance that is
widely acknowledge to possess the appropriate quality within the
specified context, and whose assigned content is accepted without
requiring comparison with another chemical substance.
Secondary reference substance (or standard):A substance whose
characteristics are assigned and/or calibrated by comparison with a
primary reference substance may be less than for a primary
reference substance Note: often referred to as an in-house working
standard.
 REFERENCE MATERIAL Cont
The lab should have necessary above said materials for testing,
calibration, validation & verification of a sample or equipment or
instrument or devices and such materials should be traceable to
agency authorized by Govt. of India or international body.
The lab should prepare working standards by comparing with
reference standards and shall be routinely checked for their purity,
identity, loss on drying or on water, impurity and assay etc. thereof
register should be maintained containing the details like source of
supply, code number of reference material, date of receipt, batch
number, storage condition, date of expiry, date of mfg. and other
details like assay value, water content etc.
The working standards should be checked before use for testing to
ensure that it has not deteriorated or decomposed during storage.
All the above said materials should be stored at appropriate storage
conditions.
The lab should have proper microbial stock cultures & SOP should be
prepared for Sub cultures, preservation, storage (NMT 5 passages).
 INTERNAL QUALITY SYSTEM AUDITS
Laboratory Building & surroundings
Premises (including Animal House)
Personnel
Equipments
Chemicals & Reagents
Good House keeping and safety
Maintenance, calibration & validation of equipments
Reference materials
Microbial cultures
Aseptic areas (microbiology and sterility if applicable)
Quality system
Storage of starting materials and finished products
Documentation
Sanitation and Hygiene
SOP`s
Protocols & Specifications Archive
Raw data,
Storage & Archival
Corrective actions on previous reports
PROTOCOLS, RAW DATA & SPECIFICATION ARCHIVE

Specification: A list of detailed requirements (acceptance criteria for the

prescribed test procedures) with which the substance or pharmaceutical
product has to conform to ensure suitable quality.
Protocol: Protocol is the documentation of all necessary specifications,
calibrations, operating ranges, etc. Environmental factors such as
temperature, humidity, barometric pressure, and other factors can often
have effects on results.
Raw data :refers to the laboratory work sheet, note books or analysis
sheet, records, memorandum, notes or extract copies thereof that may
be the results of general observations and other activities of raw data
includes written notes, photographs, software, drawings, spectral
charts, computer print outs, dictated observations or recorded data
from automated equipments, calibration records, record on receipt of
animals, results of environmental monitoring etc. if any change in the
raw data a single line shall strike through the data with signature and
date.
The data integrity and security shall be maintained and not allowed for
unauthorized person.
 STORAGE & ARCHIVAL

Residual sample shall be retained under proper storage

condition for period of one year after the final report.
The lab should have well defined plan procedure for the
identification, collection, indexing, retrieval, storage,
maintenance and disposal of all quality documents.
The lab should have well archive for storage of documents to
prevent modification, damage or deterioration or loss.
The original documents should be stored in secured area with
restricted entry.
Paper documents should not be stored under high humidity.
A photocopy of the thermal paper shall be retained.
The documents should be retained as per the D & C Rules.
 Schedule M
GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF
PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL
PRODUCTS
 Schedule M - Components
Part 1- Good Manufacturing Practices for Premises and Materials.

Part 1 A Specific requirements for Manufacture of Sterile Products,

Parenteral preparations (Small volume Injectables and Large Volume
Parenterals) and Sterile Ophthalmic Preparations.

Part 1 B Specific Requirements for Manufacture of Oral Solid Dosage

forms (Tablets and Capsules)

Part 1 C Specific Requirements for Manufacture of Oral Liquids (Syrups,

Elixirs, Emulsions and Suspensions)

Part 1 D Specific Requirements for Manufacture of Topical Products i.e.,

External Products ( Creams, Ointments, Pastes, Emulsions, Lotions,
Solutions, Dusting Powders and Identical Products)

Part 1 E Specific Requirements for Manufacture of Metered Dose

Inhalers (MDI)

Part 1 F Specific Requirements of Premises, Plant and Materials for

Manufacture of Active Pharmaceutical Ingredients ( Bulk Drugs)

Part 2 Requirements of Plant and Equipment

 Schedule M Components contd.

Schedule M I - Requirements of Factory Premises for

manufacture of Homoeopathic Preparations.
Schedule M II Requirements of Factory Premises for
manufacture of Cosmetics.
Schedule M III Requirements of Factory Premises for
manufacture of Medical Devices.
 Schedule M
Part 1
Good Manufacturing Practices for
Premises and Materials
 Part 1
1. General Requirements

1.1. Location and Surroundings

1.2. Building and Premises Confirm to Factories Act, 1948 (63 of 1948)
(i) Compatible with other drug manufacturing Operations in the same
Premises
(ii) Adequately provided with working space for orderly placement of
equipment, material and movement of personnel
a. Avoid risk of mix up
b. Avoid risk of cross- contamination
(iii) Designed to prevent entry of insects, rodents .
(iv) Air conditioned To maintain temp. and Humidity. For operation
and personnel.
(v) Drainage system as specified for product categories.
(vi) Smooth surface, ease of cleaning. Maintain record of cleaning.
1.3. Water System Validated system for treatment of water. Purified water
to be used for all operations except washing and cleaning where
potable water may be used.
 Part 1
1. General Requirements

1.4. Disposal of Waste

(i) Disposal of Effluent and Sewage as per EPCB.
(ii) All bio-medical waste to be disposed as per the provisions of
Bio-Medical Waste (Management and Handling) Rules, 1996.
(iii) Additional precautions to be taken for storage and disposal of
rejected drugs.
(iv) Provision to be made for proper and safe storage of waste as per
hazard level.