DRUGS AND COSMETICS RULES, 1945
The Drugs
and Cosmetics Rules, 1945 have many Schedules which provide specific
requirements related to drugs, cosmetics, manufacturing, testing, labeling,
licensing, pharmacy premises, and other regulatory matters.
Schedule A – Forms
For
applications, licences, certificates, reports and other regulatory procedures
under the Rules.
Schedule B – Fees for Analysis
Fees payable for the analysis or testing of
drugs in prescribed laboratories.
Schedule C – Biological and Special Products
Biological
and special products such as:
- Sera
- Vaccines for parenteral
injection
- Toxins
- Antigens
- Antitoxins
- Insulin
- Adrenaline preparations
- Parenteral antibiotics
- Blood grouping sera
- Bacteriophages
- Ophthalmic preparations
Example: Anti-snake venom serum, insulin,
vaccines.
Schedule C(1) – Other Special Products
Special products that are subject to specific regulatory requirements. Eg:
·
Digitalis
and preparations containing Digitalis
·
Ergot and preparations containing Ergot
·
Fish
liver oil and preparations containing it
·
Vaccines
not intended for parenteral administration
·
Non-parenteral
antibiotics
·
In-vitro
blood grouping sera
·
Certain in-vitro diagnostic device
Schedule D – Exemptions Regarding Import
Specifies
requirements and exemptions relating to the import of certain drugs and
substances under specified conditions.
Schedule E(1) – Poisonous Substances
List of
poisonous substances used in Ayurvedic, Siddha and Unani medicines.
Ahipena
– Papaver somniferum (except seeds)
Arka
– Calotropis
Bhallataka
– Semecarpus anacardium
Bhanga
– Cannabis sativa (except seeds)
Danti
Dhattura
Gunj
Jaipala
Karaveera
Vatsanabha
Visha-mushti
– Strychnos nux-vomica
Schedule F – Standards for Biological Products
Requirements
and standards relating to specific biological and special products. Eg:
·
Vaccines
·
Tetanus
toxoid
·
Anti-snake
venom serum
·
Rabies
vaccine
·
Sera
·
Toxins
·
Antitoxins
·
Insulin
·
Blood and
blood products
Schedule G – Drugs Requiring Medical Supervision
Required
to be used under medical supervision and carry the prescribed cautionary
statement. “Caution: It is dangerous to take this preparation
except under medical supervision.”
Certain
insulin preparations
Certain
hypoglycaemic drugs
Certain
antineoplastic drugs
Certain
antihistamines etc.
Easy
Memory: G = Medical Guidance
Schedule H – Prescription Drugs
Sold by
retail only on the prescription of a Registered Medical Practitioner. Eg:
·
Amoxicillin
·
Azithromycin
·
Warfarin
·
Prednisolone
·
Phenytoin
· Amlodipine
Schedule H1 – Drugs with Stricter Control
Schedule
H1 drugs require prescription and additional record-keeping
requirements.
·
Cefixime
·
Ceftriaxone
·
Cefotaxime
·
Cefoperazone
·
Azithromycin
·
Levofloxacin
· Moxifloxacin
Schedule J – Diseases and Ailments
Schedule J specifies diseases and
ailments in respect of which a drug or cosmetic cannot claim to prevent
or cure, as specified under the Rules.Diabetes
·
Cancer
·
Tuberculosis
·
Asthma
·
Epilepsy
·
Heart
disease
·
Hypertension
·
Leprosy
·
Paralysis
·
Sexual
impotence
Schedule K – Exemptions
Specifies classes of drugs that are
exempted from certain provisions of the Rules, subject to specified
conditions.
Schedule M – Good Manufacturing Practices (GMP)
Good
Manufacturing Practices (GMP) and requirements relating to premises, plant,
equipment, sanitation, production and quality control in pharmaceutical
manufacturing.
·
Clean
manufacturing area
·
Trained
workers
·
Equipment
maintenance
·
Documentation
·
Quality
testing
·
Proper
storage
Schedule N – Pharmacy Requirements
Schedule
N specifies the minimum requirements of premises and equipment for the
efficient running of a pharmacy.
·
Weighing
balance.
·
Measuring
cylinders and other dispensing equipment.
·
Mortar
and pestle, spatula, etc., where required.
·
Records
·
Proper
racks, shelves and cabinets.
·
Refrigeration
for medicines requiring cold storage.
·
Separate
storage for poisonous, expired and damaged medicines etc.
Schedule P – Life Period of Drugs
Specifies the life
period/shelf life of specified drugs under prescribed storage conditions.
Schedule P(1) – Pack Sizes
Prescribed pack sizes for certain drugs Eg.-
·
Albendazole
suspension → 10 mL
·
Atenolol
tablets → 14 tablets
·
Isoniazid
syrup → 200 mL
Schedule S – Standards for Cosmetics
Specifies
standards for certain cosmetics, including requirements based on applicable BIS
specifications.
Schedule T – GMP for Ayurvedic, Siddha and Unani
Drugs
Good
Manufacturing Practices (GMP) for Ayurvedic, Siddha and Unani medicines.
·
Ayurvedic
Churna – e.g., Triphala Churna
·
Ayurvedic
Asava/Arishta – e.g., Dashmoolarishta
·
Siddha
medicine – traditional Siddha formulations
·
Unani
medicine – e.g., Sharbat-e-Sadar
·
Taila
(medicated oil) – e.g., Mahanarayan Taila
Schedule U / U(I)
– Manufacturing and Testing Records
Contains
particulars to be maintained in manufacturing records and records of raw
materials, including batch number, ingredients, quantities, analytical report
references, production and packing details, release date and signature of
responsible expert.
Schedule V – Standards for Patent or Proprietary
Medicines
Gives
standards for patent or proprietary medicines, including standards for
vitamin-containing preparations and general requirements for different dosage
forms.
Schedule X – Drugs under Strict Control
Drugs
that are subject to particularly strict controls relating to prescription,
storage, record keeping and other requirements.
·
Amphetamine
·
Methylamphetamine
·
Methylphenidate
·
Secobarbital
·
Pentobarbital
·
Amobarbital
Easy Mnemonic:
“Good Health Has More Necessary Protection; Standards, Traditional
medicines and Xtra control.”
G – Health/medical supervision
H – Prescription
H1 – More control
M – Manufacturing/GMP
N – Necessary pharmacy requirements
P – Protection/life period
S – Standards of cosmetics
T – Traditional medicine GMP
X – Xtra strict control
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