Preparation of Documents for Export Registration: Introduction: A manufacturer holding a valid license copy in Form-25 and Form-28 can obtain a No Objection Certificate from Zonal/Sub Zonal offices of Central Drugs Standard Control Organization (CDSCO) for export purposes only for approved/unapproved new drugs/banned drugs from India.
Purpose: Requirement for the common submission format for issuance of No Objection Certificate for export of approved/unapproved new drugs/banned drugs from India. This document is made as per guidelines issued by the Ministry of Health and Family Welfare for Export purposes and Rule 94 of the Drugs and Cosmetic Act, 1940.
The following documents are required to be submitted in the following manner and order for the issue of the No Objection Certificate for export of drugs from India:
1. Covering Letter: The covering letter is an important part of the application and should specify the intent of the application. The list of documents that are being submitted as well as any other important and relevant information may be provided in the covering letter. The covering letter mentioning a list of products to be exported indicating the name of the drug dosage form, composition, and strength, packet size along with quantity and country to be exported duly signed and stamped by the authorized signatory, indicating the name and designation of the authorized signatory along with the name and address of the firm. Each application should be made by the manufacturer only.
2. Purchase order: Order from the foreign buyer either in the name of the manufacturer or in the name of trader mentioning list of products to be exported indicating the name of the drug, dosage form, composition and strength, packet size duly signed by the competent authority with specific destination point of the importing country. It should be signed by the authority with a valid purchase order number and a recent date not more than 6 months before the application made by the firm.
3. Manufacturing License: The license issued by the State Licensing Authority should be enclosed along with each application for the required location to manufacture the drug for export purposes.
4. Performa Invoice: A copy of the Performa invoice from the importing country should accompany the application for import of unapproved Active Pharmaceutical Ingredients, used in the drug formulation, it should be duly signed by the competent authority.
5. Registration Certificate:
- For the export of drugs which are banned in India by the Central Government, which comes under the list of drugs prohibited for manufacture and sale through gazette notifications under section 26-a of Drugs and Cosmetics Act, 1940 by the Ministry of Health and Family Welfare.
- A copy of the registration certificate from the specific importing country along with the composition and strength of the drug should accompany the application.
- Registration certificate should be provided in the name of the manufacturer.
Rules Related to Export of Drugs from India
(A) Rule 94: Packing and labeling of drugs other than Homeopathic Medicines
(i) Labels on packages or containers of drugs for export should be adapted to meet the specific requirements of the law of the country to which the drug is to be exported.
- Name of the drug,
- The name, address of the manufacturer, and the number of the license under which, the drug has been manufactured,
- Batch or lot number,
- Date of expiry, if any.
(ii) Each consignment of export should be accompanied by a requisite import license from the importing country.
(iii) The applicant should obtain a No Objection Certificate from the Drugs Controller, India for the manufacture of such formulations to be exported with code number against each export order along with a certificate from the regulatory authority of the importing country controlling Narcotic Drugs and Psychotropic Substances that they do not have any objection for the import of the drug with a code number.
(iv) The State Licensing Authority should issue the manufacturing license for these formulations on each export order based on a No Objection Certificate from Drugs Controller, India.
(v) A No Objection Certificate should be obtained from the Drugs Controller, India for export of each consignment.
(vi) A No Objection Certificate should be obtained from the Narcotic Commissioner of India, Gwalior for the export of each consignment of the drug.
(vii) The provisions of Rules 96 to 101 inclusive, should not apply to medicine made up ready for treatment, whether after or without dilution, which is supplied on the prescription of a registered practitioner provided that the medicine is labeled with the following particulars:
- The name and address of the supplier,
- The name of the patient and the quantity of the medicine,
- The number representing the serial number of the entry in the prescription register,
- The dose, if the medicine is for internal use,
- The words – FOR EXTERNAL USE ONLY should be printed on the label if the medicine is for external application.
(B) Rule 95: Prohibition of sale or distribution unless labeled: Subject to the other provisions of these rules, no person should sell or distribute any drug (including a patent or proprietary medicine) unless it is labeled.
(C) Rule 96: Manner of Labeling: The following particulars should be either printed or written in indelible ink and should appear conspicuously on the label of the innermost container of any drug and on every other covering in which, the container is packed, namely:
(i) The name of the drug:
(a) For drugs included in the Schedule For Schedule F (1), the name was given therein.
(b) For drugs included in the Pharmacopoeias and official compendia of drug standards prescribed in Rule 124, the name or synonym specified in the respective official pharmacopeias and official compendia of drug standards followed by the letters LP. or, as the case may be, by the recognized abbreviations of the respective official pharmacopeias and official compendia of drug standards.
(c) For drugs included in the National Formulary of India, the name or synonym specified therein is followed by the letters NFL.
(d) For other drugs, the international non-proprietary name, if any, published by the World Health Organization or not published the name descriptive of the true nature or origin of the substance.
Guidelines for the Export of Drugs issued by Ministry of Health and Family Welfare
During the issue of NOC’s for the manufacturing of new (Unapproved) drugs solely for export, the following conditions should be taken into consideration:
- The application should provide a copy of the valid export order and NOC will be issued on a case by case basis against each such order.
- The applicant should identify the premises where the drug will be manufactured for export.
- The applicant should mention whether the batch to be exported has undergone Quality control testing or should be tested at the destined site.
- The applicant should ensure that the drug(s) manufactured based on NOC given as per (1) above its exported and that no part of it is diverted for domestic sale in India.
- The applicant should make available for inspection of the appropriate authorities, on completion of the export orders, information regarding each consignment dispatched, remaining stock of drug and related raw materials, and intermediates in hand.
- The applicant should ensure the physical destruction of all unexported quantities of drugs. This should be included as a condition of the manufacturing license issued to the applicant by the State Licensing Authority.
- The applicant should ensure that the drug for which, NOC has been given should cease to be manufactured or exported if the drug is prohibited in the future in the country or the importing country.
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