SCHEDULE D (II)
(See rule 21 (d) and rule 24 A)
1. GENERAL
1.1 Name of the drug/formulation/special product, a brief description and the therapeutic class to which it belongs.
1.2 Regulatory status of the drug. Free Sale Certificate and/or Certificate of Pharmaceutical Products (CPP) issued by the Regulatory Authority of the country of origin. Free sale approval issued by the Regulatory Authorities of other major countries.
1.3 Drugs Master File (DMF) for the drug to be registered (duly notarised).
1.4 GMP Certificate in WIIO formats or Certificate of Pharmaceutical Products (CPP) issued by National Regulatory Authority of the Country of origin (duly notarised).
1.5 List of countries where marketing authorisation or import permission for the said drug is granted with date (respective authorisation shall be enclosed).
1.6 List of countries where marketing authorisation or import permission for the said drug is cancelled/withdrawn with date.
1.7 List of countries where marketing authorisation or import permission for the said drug is pending since (date)
1.8 Domestic price of the drug in the currency followed in the country of origin.
1.9. List of countries where the said drug is patented.
2. CHEMICAL AND PHARMACEUTICAL INFORMATION OF DRUGS.
2.1 Chemical name
Code name or number, if any
Non-proprietary or generic name, if any
Structure
Physico-chemical properties
2.2 Dosage form and its composition,
Qualitative and Quantative composition in terms of the active substance(s)
and excipient(s)
List of active substance(s) separately from the constituent(s) of excipients.
2.3 Specifications of active and inactive ingredients including pharmacopeal references.
2.4 Source of active ingredients(s), name and address.
2.5 Tests for identification of the active ingredients,
Method of its assays and tests for impurity profile with reference standards for the impurities (Protocol to be submitted alongwith reference standards for the impurities/relative substances)
2.6 Outline method and now chart of manufacture of the bulk drug or finished formulation or special product.
2.7 Detailed test protocol for the drug with pharmacopeal reference or in house specification as approved by the registration authority, in the country of origin.
2.8 Stability data including accelerated stability and real time stability analysis.
2.9 Documentation on pack size
2.10 Numerical expression on EAN bar code on the labels and cartons.
2.11 Safety documents on containers and closer.
2.12 Documentation on storage conditions.
2.13 Three samples of medicinal product/drug and other packaging are to be submitted with batch certificates. Additional samples as well as reference substances with batch certificates including date of manufacture, shelf life, storage conditions of reference substance may be required both during registration procedure and during validity of registration decision.
2.14 Batch test reports/certificate of five consecutive production batches in details of the medicinal product are to be submitted for every site of manufacturing premises.
2.15 Manner of labeling as per rule 96 of the Drugs and Cosmetics Rules, 1945.
2.16 Package insert.
2.17 Details of safety handling procedure of the drug.
2.18 Details of PMS study report for marketing period not exceeding five years.
3. BIOLOGICAL AND BIOPHARMACEUTICAL . INFORMATION OF DRUGS.
3.1 Biological control tests applied on the starting material, if applicable.
3.2 Biological control tests applied on the intermediate products, if applicable.
3.3 Biological control tests applied on the finished medical products, if applicable.
3.4 Stability of the finished products in terms of biological potency of the drug, if applicable.
3.5 Sterility tests, if applicable, specification and protocol therein.
3.6 Pyrogen tests, if applicable specification and protocol therein.
3.7 Acute and sub-acute toxicity tests, if applicable specification and protocol therein.
3.8 Bio-availability studies and bio-equivalence data, if applicable.
3.9 Data relating to the environmental risk assessment for r-DNA products.
3.10 Other information relevant under the section.
4. PHARMACOLOGICAL AND TOXICOLOGICAL INFORMATION OF DRUGS
Executive summary of the product is to be submitted mentioning the specific and general pharmacological actions of the drug and pharmacokinetic studies on absorption, metabolism, distribution and excretion. A separate note is to be given on acute and sub-acute toxicity studies and long term toxicity studies. . Specific studies on reproductive toxicity, local toxicity and carcinogenic activity of the drug is to be elaborated, as far as possible.
5. CLINICAL DOCUMENTATION
A new drug as defined under rule 122-E of he Drugs and Cosmetics Rules, 1945 is required to be permitted separately by the licensing authority under rule 122-A of the said rules prior to its registration. Such a new drug requires a brief summary on clinical documentation alongwith permission under 122-A of the said rules for its Registration Certificate.
6. LABELLING AND PACKAGING INFORMATION OF DRUGS.
6.1 Labels should conform as per the specifications under the Drugs and Cosmetics Rules, 1945.
6.2 Package insert should be in English and shall indicate the following therapeutic indications:
Posology and method of administration.
Contra-indications.
Special warnings and special precautions for use, if any.
Interaction with other medicaments and other forms of interation.
Pregnancy and lactation, if contra-indicated.
Effects of ability to drive and use machines, if contra-indicated.
Undesirable effect/side effect .
Antidote foe overdosing:
6.3 Package insert should indicate the following pharmaceutical information List of excipients.
Incompatibilities.
Shelf life in the medical product as packaged for sale.
Shelf life after dilution or reconstitution according to direction.
Shelf life after first opening the container.
Special precautions for storage.
Nature and specification of the container.
Instructions for use/handling
