Procedure for export of Indian drug product in overseas market

Procedure for export of pharmaceutical products

Background

pharmaceutical Procedure for export of pharmaceutical Indian drug product in overseas market India holds a prominent position globally in the pharmaceutical industry, ranking third. Oversight of these industries falls under the Ministry of Health & Family Welfare and the Ministry of Chemicals & Fertilizers. Despite its substantial market presence and economic growth, India faces challenges in funding sophisticated Research and Development (R&D). To address this, India has opened its pharmaceutical market to multinational corporations (MNCs) and promotes drug trade both domestically and internationally. The majority of drugs for the Indian market are imported primarily from the European Union, followed by North America and Asia. India’s import and export operations are guided by the “EXIM” policy, which aims to enhance both the quantity and quality of R&D activities.

The Central Drugs Standard Control Organization (CDSCO) oversees drug imports and exports through 11 port offices nationwide. It regulates drug manufacture, sale, import, export, and clinical research in India through several key acts and rules including the Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948; Drugs and Magic Remedies Act, 1954; Medicinal and Toilet Preparation Act, 1956; Narcotic and Psychotropic Substances Act, 1985; and the Drugs (Prices Control) Order, 1995.

While central authorities approve new drugs and oversee clinical trials, set standards for drug quality, and coordinate with state drug control organizations, state authorities manage drug manufacturing, sales, and distribution within their jurisdictions. They license drug testing laboratories, approve drug formulations, and conduct inspections before and after licensing.

India’s pharmaceutical sector has adapted to the new patent regime, complying with WTO and TRIPS agreements, ushering in product patents and boosting technological advancements in R&D. The industry’s strengths lie in producing 70% of bulk drugs domestically and nearly all required formulations, thanks to low production costs and robust R&D capabilities. This self-reliance has made the industry attractive for investments and trade opportunities.

In addition to its strengths in manufacturing and exporting allopathic medicines, India boasts a robust presence in traditional systems of medicine such as Ayurveda, Unani, Siddha, Yoga, Naturopathy, and Homeopathy. These systems are widely practiced and recognized within the country.

India also demonstrates several key strengths in the pharmaceutical sector:

• It possesses a strong pool of scientific, innovative, and technical manpower.
• The pharmaceutical sector enjoys an increasing balance of trade.
• It serves as an efficient and cost-effective source for producing generic drugs, particularly those nearing patent expiration within the next five years.
• India is recognized as an excellent center for conducting clinical trials, leveraging its diverse population.
• The biotechnology industry in India is rapidly growing and holds substantial potential in the global market.

Rule 94 pertains to the packing and labeling of drugs other than Homeopathic Medicines for export: pharmaceutical

1. Labels on packages or containers of drugs intended for export must comply with the specific requirements of the destination country’s laws. The label should include:
   • Name of the drug
   • Name and address of the manufacturer
   • License number under which the drug was manufactured
   • Batch or lot number
   • Date of expiry
2. Rules 96 to 101 do not apply to medicines that are ready for treatment, whether diluted or undiluted, and are supplied based on a registered practitioner’s prescription. For such medicines, the label must contain:
   • Name and address of the supplier
   • Name of the patient and quantity of the medicine
   • Serial number corresponding to the entry in the prescription register
   • Dosage information if the medicine is for internal use
   • Label must state “FOR EXTERNAL USE ONLY” if the medicine is for external application.

Rule 96 specifies that certain details must be clearly displayed on the label of the innermost container of any drug and on all outer packaging. These particulars include the name of the drug as listed in Schedule F or Schedule F (1) for relevant drugs, or the name/synonym specified in official pharmacopoeias and compendia of drug standards under Rule 124. The names must be accompanied by “I.P.” or appropriate abbreviations as specified in the respective pharmacopoeias and drug standards.

For drugs listed in the National Formulary of India, the label must display the specified name or synonym from the National Formulary of India, followed by “N.F.I.”. For other drugs, the label should feature the international non-proprietary name if available and published by the World Health Organization. If such a name is not published, the label should include a name that accurately describes the substance’s true nature or origin.

The Ministry of Health and Family Welfare has issued guidelines for the export of drugs, outlining specific conditions for the issuance of NOCs (No Objection Certificates) for manufacturing new (unapproved) drugs solely for export purposes:

1. The application for an NOC must include a copy of a valid export order, and NOCs will be issued on a case-by-case basis for each such order.
2. The applicant must specify the manufacturing premises where the drug will be produced for export.
3. The applicant should indicate whether the batch intended for export has already undergone quality control testing or will be tested at the destination site.
4. It is the responsibility of the applicant to ensure that drugs manufactured under the NOC are exported entirely and not diverted for domestic sale within India.
5. Upon completion of export orders, the applicant must provide appropriate authorities with information regarding each dispatched consignment, as well as details about remaining stocks of the drug and related raw materials and intermediates.
6. All unexported quantities of drugs must be physically destroyed, as mandated by the manufacturing license issued by the State licensing authority.
7. The applicant must discontinue manufacturing or exporting the drug if it becomes prohibited in either the country of manufacture or the importing country in the future.

To apply for a No Objection Certificate (NOC) for exporting drugs from India, the following documents must be submitted in the specified manner and order:

1. Covering Letter:
   • A formal letter outlining the purpose of the application and details of the export order.
2. Purchase Order:
   • A purchase order from the foreign buyer, addressed to either the manufacturer or trader, listing the products to be exported. It should clearly specify the name of the drug, dosage form, composition, strength, and pack size. The purchase order must be signed by a competent authority, include a valid purchase order number, and have a date no more than 6 months prior to the application.
3. Manufacturing License:
   • A copy of the manufacturing license issued by the relevant Indian authority.
4. Proforma Invoice:
   • If applicable, a proforma invoice from the importing country specifically for unapproved Active Pharmaceutical Ingredients (APIs) used in the drug formulation. This document must be signed by a competent authority.
5. Registration Certificate:
   • A registration certificate as required by the Common Submission Format for the Issue of NOC for Export.

These documents must be organized and submitted in the order listed above to facilitate the processing of the NOC application for drug export from India.