ediscussion on 'Drug regulatory Laws'

[Guest guest]

Goodafternoon!The various categories,rules,and schedules are

discussed here in this session.

The Act and rules have been amended from time to

time-major one made in 1982.

Accordingly Schedules E I and L were deleted, Schedules

G and H revised & expanded and new schedule X was added.The most recent amendment

is the addition of Schedule Y in the year 2005.

As compared to earlier 2 categories ie

(i)Schedule C and C1 drugs

(ii)Drugs other than those specified in Schedule C and

C1

There are 4 categories of drugs now:

1.Drugs specified in Schedule C,C1 and X.

2. Drugs not specified in Schedule C, C1 and X.

3. Drugs specified in Schedule C, C1 excluding those

specified in Schedule X.

4. Drugs specified in Schedule X.

Schedules M (GMP) and Y were introduced in 1988.

This Act extends to whole of India.

In Jammu and Kashmir: the chapter relating to import of

drugs and cosmetics takes effect only from such date after the commencement of

the Drugs and Cosmetics (Amendment)1972,as the Central govt. may by

notification in the official Gazette,appoint in this behalf.

Drugs and Cosmetic rules have been divided into 18n

parts each dealing with a particular

subject. There are 2 Schedules to the Act and 23 Schedules to the Rules which

are as follows:

Schedules

to the Act:

1st Schedule: Names of books under Ayurvedic

, Siddha and Unani Tibb systems.

2nd Schedule: Standard to be compiled with

by imported drugs and by drugs manufactured for sale, stocked or exhibited for

sale, sold or distributed.

Additionally following appendices are also prescribed:

Appendix I-Data

required to be submitted with

application for permission to market a new drug.

Appendix II - Format

for submission of clinical trial reports.

Appendix III - Animal toxicity requirements

for clinical trials and marketing of a new drug.

Appendix IV -number

of animals for long term toxicity studies.

Appendix V-Patient

consent form for Participation

in a Phase I clinical trial.

Appendix VI-4 groups of Fixed dose combinations and their data requirements.

Schedules to the

Rules:

A-Proforma

for application for the licences,issue and renewal of licences, for sending

memoranda under the Act.

B-Rates

of fee for test or analysis by the Central Drugs Laboratory or the

govt.Analyst.

C-List

of biological and special products whose import,sale,distribution and

manufacture are governed by special provisions.

C1-List

of other special products whose import,sale,distribution and manufacture are governed

by special provisions.

D-List

of Drugs exempted from the provisions of import of drugs.

D1-Information

and undertaking to be submitted by the manufacturer with the application form

for a registration certificate.

D2-Information

to be submitted by the manufacturer with the application form for registration

of a bulk drug/formulation/special product for its import into India.

E1-List

of poisonous substances under the Ayurvedic (including Siddha) and Unani

systems of medicine.

F-Part

XII B-Requirement for the functioning

and operation of the blood bank and/or for preparation of blood

components.

F1-Part

I-Provisions applicable to the production of

bacterial and viral vaccines.

Part

II-Provisions applicable to the production of all sera

from living animals.

Part

III-Provisions applicable to the manufacture and

standardization of diagnostic agents(bacterial origin).

F2

- Standards for surgical dressings.

F3

- Standards for sterilized umbilical tapes.

FF

- Standards for ophthalmic preparations.

G-

List of substances that are required to be used only

under medical supervision and which are to be labeled accordingly.

H-

List of prescription drugs.

J-

Disease or ailments which a drug may not purport to prevent or cure.

K-Drugs

exempted from certain provisions relating to the manufacture of drugs.

M-Good

manufacturing Practices (GMP)requirements of factory premises, plants and

equipment for Pharmaceutical products.

Part I- GMP for premises and materials.

Part I A- Specific requirements for manufacture of

sterile products, parenteral preparations (small volume injectionables and

large volume parenterals) and sterile ophthalmic preparations.

Part I B-Specific Requirements for manufacture of oral

solid dosage forms (tablets and capsules).

Part I C-Specific requirements for manufacture of oral

liquids(syrups, elixirs, emulsions, suspensions)

Part I D-Specific requirements for manufacture of

topical (external) products like creams , ointments, pastes, emulsions,

lotions, solutions ,dusting powders and identical products.

Part I E - Specific requirements for manufacture of

metered dose inhalers (MDI).

Part I F- Specific requirements of premises

,plants,materials for manufacture of active pharmaceutical ingredients (bulk

drugs)

PART

II -Requirements of plant and equipment.

M1-

Requirements of factory premises for the manufacture of

homeopathic preparations.

M2-Requirements

of factory premises for the manufacture of cosmetics.

M3-Requirements

of factory premises for manufacture of medical devices.

N-List

of minimum equipment for efficient running of a Pharmacy.

O-Standards

for disinfectant fluids.

Part I- Provisions applicable to black fluids and white

fluids.

Part II- Provisions applicable to other fluids.

P-Life

periods of drugs.

P1-Pack

sizes of drugs.

Q-Part

I –List of Dyes,colours,and pigments permitted in cosmetics .

Part II – List of colours permitted in soaps.

R-Standards

for condoms made of rubber latex intended

for single use and other mechanical contraceptives.

R1

-Standards for medical devices.

S-Standards

for cosmetics.

T-GMP

for Ayurvedic,Siddha and Unani medicines.

Part I- Good manufacturing practices.

Part II A- List of machinery ,equipment and minimum

manufacturing premises for manufacture of various categories of Ayurvedic,

Siddha system of medicines.

Part II B- List of machinery,equipment and minimum

manufacturing premises for manufacture

of various categories of Unani system of medicines.

Part II C-List of equipment Recommended for in-house

quality control section.

U-Particulars

to be shown in manufacturing ,raw materials and analytical records of drugs.

U1-Particulars

to be shown in manufacturing ,raw materials and analytical records of

Cosmetics.

V-Standards

for patent or proprietary medicines.

W-List

of drugs which are to be marketed under generic names only.

X-List

of Drugs whose import,manufacture and sale,labeling and packaging are governed

by special provisions.

Y-Requirements

and guidelines on clinical trials for import and manufacture

of new drugs.

I would further

elaborate Schedule Y.

contd......