There are two Schedules to the Act and 35 Schedules to the Rules.
Schedules to the Act and Rules
There
are two Schedules to the Act and 35 Schedules to the Rules.
1. First Schedule: It comprises the
list of books of references for Ayurvedic,
Siddha and Unani medicines. There are 57 books of Ayurveda, 30 books of Siddha
and 13 of Unani Tibb systems listed in the Schedule which are used for
different formulations in accordance with the provisions of the Act.
2. Second Schedule: It comprises of the standards to be complied with for imported drugs, manufacture of
drugs, their sale, stocking and storage etc.
Schedule A : Different Forms for application to
procure licence, renewal of licence, and for all other activities.
Schedule B : Rates of fees
charged for analysis by COL or State Drugs Laboratories.
Schedule C : List of biological and other special
products governed by special provisions.
Schedule C (I) : List of other special products
governed by special provisions
Schedule D : Class of drugs:
extent and conditions of exemption
Schedule D (I) : Undertaking of the manufacturer or
his authorized agent required to be submitted alongwith application form for
obtaining a registration certificate.
Schedule D (II) : Undertaking of the manufacturer or
his authorized agent required to be submitted along with application form for
registration of a bulk drug or its formulation or its import into India
Schedule E (I) : List of poisonous substance under
Ayurvedic , Siddha and Unani medicines
Schedule F : Requirement for operation of blood
bank and / or preparation of blood components
Schedule F (I) : Provisions for
bacterial vaccines, viral vaccines, antisera, diagnostic antigens, etc.
Schedule F (II) : Standards for
surgical dressings
Schedule F (III) : Standards for
Umbilical tapes
Schedule FF : Standards for
ophthalmic preparations.
Schedule G : Drugs required to be
taken under medical supervision.
Schedule H : List of prescription
drugs
Schedule J : List of diseases or
ailments which a drug may not purport to prevent or cure.
Schedule K : Drugs exempted from
certain provisions related to manufacturer.
Schedule M : GMP (Good Manufacturing
Practices) comprising requirements offactory premises, plant and equipment.
Schedule M-l : Homoeopathic preparations
requirements of factory premises, plants and equipments.
Schedules M-(II) : Cosmetics -
requirements offactory premises for manufacture
Schedules M-(III): Requirements of factory
premises for manufacture of medical devices.
Schedule N : List of minimum equipment of running a
pharmacy.
Schedule 0 : Standards for
disinfectant fluids.
Schedule P : Life period of drugs
Schedule P-l : Pack sizes of drugs
Schedule Q : List of colours,
dyes and pigments permitted in cosmetics and soaps, list of colours permitted
in soaps.
Schedule R : Standards for condoms
of rubber latex and other mechanical contraceptives.
Schedule R-J : Standards for
medical devices
Schedules S : Standards for
Cosmetics
Schedules T : GMP (Good
Manufacturing Practices) for manufacture of Ayurvedic, Siddha and Unani
medicines, G.M.P., machinery, equipment minimum manufacturing premises, etc.
Schedules U : Particulars required
to be shown in manufacturing records; raw material and analytical records.
Schedules U (1) : Particulars required
to be shown in manufacturing records.
Schedules V : Standards for patent
or proprietary medicines.
Schedules X : Psychotropic
substances
Schedules Y : Requirements and
guidelines on clinical trails for import and manufacture of new drug.
Different
Forms used for variety of operations
pertaining to Drugs and Cosmetics are covered under Schedule A to Rules of DCA.
They include:
Form 1 - Memorandum to the
Central Drugs Laboratory (CDL).
Form 2 - Certificate of CDL
for test or analysis.
Form 8 - Application for
licence to import drugs except, schedule X (Roman X) and Licence for this is
issues in Form 10.
Form 8-A - Application for
licence to import schedule X drugs and licence for this is issues in Form to-A.
Form 9 - Undertaking
accompanying application for import licence.
Form 11 - Licence for import
of drugs of examination, test or analysis; while the application for this
licence is made in Form 12.
Form ll-A - Licence to import drugs by a
Government hospital or Autonomous medical institution; while the application
for this is made in Form 12-AA.
Form 12-A - Application for permit to import
small quantities of drugs for personal use while, permit is issued in Form
12-B.
Form 13 - Certificate of test
or analysis by Government Analyst under section 25 (1) of DCA, 1940.
Form 13-A - Certificate of test or analysis by
Government Analyst under Section 33 H of DCA, 1940.
Form 14-A - Application for test or analysis of
a drug from purchaser under section 26 of DCA, 1940 and the certificate for the
same is issued in Form 14-B.
Form 15 - Order requiring a person not to
dispose of stock in his possession.
Form 16 - Receipt for seized stock of drugs or
cosmetics, records, register, documents or material.
Form 17 - Intimation to
person for taking sample.
Form 17-A - Receipt for samples of drugs or
cosmetics taken where fair price is tendered.
Form 18 & 18-A - Memorandum to
Government Analyst
Form 19 - Application for grant or renewal of
a licence to sell, stock, exhibit or distribute drugs other than schedule X.
Form 19-A - Application for
grant or renewal of a restricted licence to sell, stock, exhibit or distribute
drugs by retail by dealer who does not engage qualified person. The Licence for
this is issued in Form 20-A.
Form 19-AA - Application for grant or renewal of
licence to sell, stock, exhibit or distribute drugs from a motor vehicle. The
licence for this is issued in Form 20-BB.
Form 19-B - Application for a
licence to sell, stock, exhibit, sale or distribute Homoeopathic medicine. The
Iicence for retail is issued in Form 20-C, while the licence for wholesale is given
in Form 20-D. The certificate for renewal of licence is issued in Form 20- E.
Form 19-C - Application for grant or renewal
ofa licence to sell, stock, exhibit or distribute schedule X drugs. The licence
this by retail sale is issued in Form 20-F while, the licence for the same by
wholesale is given in Form 20-G
Form 20 - Licence to sell, stock, exhibit or
distribute drugs other than specified in schedules C, C (1) and X by retail.
Form 20-B - Licence to sell, stock, exhibit or
distribute by wholsale plain drugs other than those Specified in schedules C, C
(1) and X
Form 21 - Licence to sell, stock, or exhibit
or distribute by retail Schedules C and C (I) drugs.
Form 21-A - Restricted licence to sell, stock,
or exhibit or distribute by retail schedule C (1) drugs for dealers not engaging
services of qualified person.
Form 21-B - Wholesale licence for sell, stock,
exhibit or distribute Schedules C and C (1) drugs.
Form 21-8B - Licence to sell by wholesale or to
distribute drugs specified in Schedules C and C (I) from a motor vehicle.
Form 21-C - Certificate of renewal of licence to
sell, stock, exhibit or distribute drugs.
Form 21-CC - Certificate of
renewal of licence to sell, stock, exhibit or distribute drugs by wholesale from a motor vehicle.
Form 24 - Application for grant or renewal of
manufacturing licence for drugs other than Schedules C, C (l) and X drug. The
licence for manufacture of this category is issued in Form 25.
Form 24-A - Application for grant or renewal of
a loan licence to manufacture drugs other than Schedules C, C (I) and X drug.
The loan licence for manufacture of this category is issued in Form 25-A.
Form 24-B - Application for grant or renewal of
repack licence for sale for drugs other than Schedules C, C (I) and X drugs.
The licence for repack of this category is issued in Form 25-B. The certificate
of renewal of such a repack licence for sale is issued in Form 26-B.
Form 24-C - Application of grant or renewal of a
licence for manufacture of Homoeopathic medicines or potentised preparations
from back potentcies by licensees holding licence in Form 20-C. The licence to
manufacture Homoeopathic medicines is issued in Form 25-C. The certificate of
renewal of such a licence is in Form 26-C.
Form 24-0 - Application for grant/renewal oflicence
for manufacture for sale of Ayurvedic/Siddha or Unani drugs. The licence for
manufacture of this category is issued in Form 25-0. The certificate of renewal
licence for manufacture is issued in Form 26-0.
Form 24-E - Application for grant/renewal of a
loan licence to manufacture for sale Ayurvedic /Siddha or Unani drugs. The loan
licence for manufacture of this category is issed in Form 25-E. The certificate
of renewal of loan licence to manufacture such drugs is issued in Form 26-E.
Form 24-F - Application for grant/renewal of
manufacturing licence of drugs in Schedule X and not in Schedules C and C (1).
The licence for manufacture of this category is issued in Form 25-F.
Form 26 - Certificate of
renewal of licence to manufacture other than schedule X drugs, while
certificate of renewal of loan licence to manufacture such drugs is issued in
Form 26-A.
Form 26-E-l - Certificate of Good Manufacturing
Practices (GMP) to manufacture of Ayurveda, Siddha or Unani drugs.
Form 26-F - Certificate of renewal of licence
to manufacture for sale of Schedule X drugs
Form 26-G - Certificate of renewal of licence
for operation of Blood Bank for processing human blood or its components.
Form 26-H - Certificate of renewal of licence
to manufacture large volume parenterals, sera and vaccines of Schedules C and C
(1) categories.
Form 26-1 - Certificate of renewal oflicence
for manufacture of blood products.
Form 27 - Application for grant/renewal of a
manufacturing licence of drugs in Schedules C and C (1), excluding those specified
in Part X B and schedule X. The licence for manufacture for this category is
issued in Form 28.
Form 27-A - Application for grant/renewal of a
loan licence to manufacture Schedules C and C (1) drugs, excluding those
specified in Part X B and schedule X. The licence for manufacture of this
category of drugs is issued in Form 28-A.
Form 27-8 - Application for grant/renewal of
manufacturing licence for Schedules C, C (1) and X. The licence for manufacture
of this category is issued in Form 28-8.
Form 27-C - Application for
grant/renewal of a licence for Operation of 8lood Bank for processing of whole
blood and / or preparation of blood components. The licence for this is issued
in Form 28-C.
Form 27-D - Application for grant or renewal of
a manufacturing licence oflarge volume parenterals/sera and vaccines excluding
Schedule X drugs.
Form 27-E - Application for grant/renewal of
manufacturing licence of blood products.
Form 28-D - Licence to manufacture for sale or
distribution of large volume parenterals, sera and vaccines specified in
Schedules C and C (l) excluding those specified in Schedule X
Form 28-E - Licence to manufacture and store
blood product for sale or distribution.
Form 29 - Licence to manufacture drugs for
examination, test or analysis. Application for the same is made in Form 30.
Form 31 - Application for grant/renewal of a
licence to manufacture cosmetics. The licence for manufacture of cosmetics is
issued in Form 32, Form 31-A -Application for loan licence to manufacture
cosmetics, the loan licence for manufacture of cosmetics is issued in Form
32-A.
Form 33 - Certificate of renewal of licence
to manufacture cosmetics.
Form 33-A - Certificate of renewal of loan
licence to manufacture cosmetics.
Form 34 - Certificate of test or analysis of
cosmetic by CDL or Government Analyst.
Form 35 - Form for
maintaining Inspection Book.
Form 36 - Application for
grant/renewal for carrying out tests on drugs/cosmetics or raw materials used
in manufacture thereof on behalf of licensee for manufacture for sale of
drugs/cosmetics. Approval for the same is issued in Form 37 whereas,
Certificate of Renewal for the same is issued in Form 38.
Form 39 - Report of test or
analysis by approved institution.
Form 40 - Application for
issue ofRegistration Certificate for import of drugs into India. The
Registration Certificate is issued in Form 41.
Form 44 - Application for grant
of permission to import or manufacture a New Drug or to undertake clinical
trial.
Form 45 - Permission to
import finished formulation of a new drug.
Form 45-A- Permission to
import new bulk drug substance (raw material).
Form 46 - .Permission/Approval
for manufacture of new drug formulation.
Form 46-A - Permission/Approval
for manufacture of new bulk drug substance (raw-material)
Form 47 - Application for
grant or renewal of approval for carrying out tests on Ayurvedic, Siddha and Unani
drugs or raw material used in manufacture thereof on behalf of Licensee for
sale of Unani, Ayurveda and Siddha drugs. The approval for test or analysis of
this category is issued in Form 48 and certificate of renewal for carrying out tests
or analysis is issued in Form 49.
Form 50 - Report of test or
analysis by approved laboratory.
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