Schedules to the Act and Rules

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Chapter: Forensic Pharmacy : The Drugs and Cosmetics Act (DCA) 1940 and Rules 1945

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.

 

The Schedules to the Act

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.

 

The Schedules to the Rules

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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