DRUG SHEDULES

                           

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A — Proforma for application for the licenses, issue and renewal licenses, for sending memoranda under the Act.

B — Rates of fee for test or analysis by the Central Drugs Laboratory or the Government 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.

D-1 — Information and undertaking to be submitted by the manufacturer with the application form for a registration certificate.

D-2 — Information to be submitted by the manufacturer or his authorised agent with the application form for registration of a bulk drug/formulation/special product for its import into India.

Annexure-A   Specific information for the blood products.

Annexure-B   Specific information for the diagnostic kits.

Annexure-C    Specific information for vaccines.

D-3 — Information and undertaking to be submitted by the manufacturer or his authorised importer/distributor/agent with the application form for a registration certificate.

E1 — List of poisonous substances under the Ayurvedic                          (including Sidha) and Unani systems of medicine.

F — 

Part XIIB — Requirement for the functioning and operation of the blood bank and/or for preparation of blood components.

Part XII C I— Requirement for manufacture of blood products.

Part XII C II— Requirement for manufacture of blood products from bulk finished products.

Part XIII   —  General

F-1 — 

Part I A — Provisions applicable to the production of bacterial vaccines.

Part I B — Provisions applicable to the production of 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).

Part IV — General

F-2 — Standards for surgical dressings.

F-3 —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. 

H1— List of certain antibiotics, anti-TB drugs and habit forming drugs not to be sold by retail without the prescription of a Registered Medical Practitioner.

J — Diseases or ailments which a drug may not purport to Prevent or cure.

K — Drugs exempted from certain provisions relating to the manufacture of drugs.

L-1 — Good Laboratory Practices (GLP) and requirements of premises and equipments.

M — Good Manufacturing Practices (GMP) requirements of factory Premises,plants and equipment.

M1 — Requirements of factory premises etc. for manufacture of homeo-pathic 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.

P — Life periods of drugs.

P1 — Pack sizes of drugs.

Q — 

Part I — List of dyes, colours and pigments permitted in cosmetics and soaps.

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 of various categories Of Ayurvedic,Siddha system of medicines.

Part II-B — List of machinery, equipment and minimum manutacuieing premises for manufacture of various categories of Unani system of medicines.

Part II-C — List of equipment recommended for in-house quality control section.

Part II-D — Supplementary guidelines for manufacture of Rasaushadhies or Rasamarunthukal and Kushtajat of Ayurvedic, Siddha and Unani system of medicines.

T-A — Form for record of utilization of raw material byAyurvedic/Siddha/Unani manufacturing units.

U — Particulars to be shown in manufacturing, raw material  and analytical records of drugs.

U1 — Particulars to be shown in manufacturing, raw material and analytical records of cosmetics.

V — Standards for patent or propnetary 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 for permission to import and/or manufac of new drugs for sale or to undertake clinical trials.