Overview of Drug Export NOC
India’s pharmaceutical industry ranks high on the list of the pharmaceutical industry at the global level. In terms of value, India's ranking is thirteen, and in terms of Volume, India stands in the third position. India plays a vital role in supplying generic medicine to many countries across the globe. India has emerged as a drug manufacturing hub and research powerhouse for many years. There has been a constant growth in the export of pharmaceutical products from India, and it is also becoming a new business opportunity for many. If we see the trend, generic drug exports dominate nearly 70% of the global market, whereas patented medicines and over the counter drugs make up 21% and 9%, respectively. The top countries importing heavily from India are the USA, UK, South Africa, Russia and Nigeria. India is the world's largest exporter of generic drugs. The manufacturing cost of generic drugs is much lower in India than in the USA and Europe.
Exporting medical-related products requires a NOC, i.e. No Objection Certificate from the Drug Controller Office of India. NOC is a document by which the Drug Controller authorises manufacturers of medical products to export their Pharmaceutical products freely outside India. In India, the manufacturer holding a valid License to manufacture drugs as per Form 25 and Form 28 can obtain a Non-objection Certificate. The Central Drugs Standard Control Organisation (CDSCO) has authorised State Licensing Authority (SLA) to issue a No objection certificate (NOC) for the export of only Approved, Unapproved and Banned drugs in India with effect from August 20, 2018. An entity seeking NOC can apply to zonal / sub zonal offices of the Central Drugs Standard Control Organisation. (CDSCO)
Key points for applying Drug Export NOC
For getting NOC for approved, unapproved and banned drugs, the manufacturer must have a valid license to manufacture pharmaceutical products in India. Apart from this essential requirement following conditions must be taken into consideration.
- The drug export application must provide a valid export order, and NOC will be issued against each order on a case-to-case basis.
- Applicant must identify the site where the drug for export will be manufactured. They are also required to submit whether the batch to be exported undergone quality control testing.
- Applicants need to ensure that the Product for which NOC is to be given is only for export and by no chance it will be diverted for sale in the domestic market.
- Consignment information dispatched, stock remaining, raw material, and intermediates must be made available for inspection by the appropriate authority.
- The applicant for NOC must prove that there will be physical destruction of all leftover drugs meant for export only.
- The applicant is also required to ensure that the production or export of such drugs will be stopped if, in the future, drugs fall into the category of prohibited medications in the home country or importing country.
- The applicant must also submit all essential documents in Common Submission Format for issuance of NOC.
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Documents Required for Drug Export NOC
The following documents must be submitted in prescribed the issue of obtaining NOC for exporting Drugs outside India.
It is the essential part of every application, and it must specify the intent of the applicant. The covering letter must have a list of documents and other details required to be submitted. The letter must identify the name of the drugs, dosage, composition and strength of the medications, along with the name of the country and amount to be exported. The authorised signatory must duly sign the documents required. The authorised signatory's name and designation must also be mentioned.
Valid copy of the purchase order from the overseas buyer in the name of the manufacturer or trader in which a list of products to be exported is mentioned need to be submitted. The order must contain the name of the drug, dosage, composition and the quantity of Product required. The competent signatory authority must duly sign the purchase order, and it must have a recent date, not more than six months before the application made by the firm.
The copy of the licence issued by the competent authority to manufacture drugs for export must be enclosed with the application. Performa Invoice.
A duly signed copy of the Performa invoice from the importing country must with enclosed with the application. The invoice must be attached with the application to import unapproved Active Pharmaceutical Ingredients.
Certificate of Registration from the National Regulatory Authority of importing country (Applicable for banned drug)
The Ministry of Health and Family Welfare has provided specific rules and guidelines for the export of drug, which manufacturer has to comply with.
Corpbiz has a dedicated team of Regulatory and compliance professionals who can help provide end-to-end service for obtaining import Licenses. We have a team of expert and experienced professionals to ensure that our clients get top-line services regardless of lengthy compliance procedures. We provide on-time delivery of government licensing and Registration. Facilitate comprehensive support throughout the Registration process and hassle-free get NOC for drug export.
Frequently Asked Questions
The central Drugs standard control organisation (CDSCO) regulates the import and exports of the drugs in India .There are 11 ports in a different part of the country where export and import is done. Apart from import and export, CDSCO regulates sales, manufacturing and clinical research in India.
Documents required for getting a Drug export License:
- Company PAN number
- Certificate of incorporation
- Bank account statement and other Financial Documents
- IEC number
- Bankers Certificate and other Financial Documents
- Indian trade classification of the Product
- Proof of ownership of business premises or Rental Agreement
- Cancelled cheque
- WHO: GMP certificate
- Details of Product, dosage, combination, strength, visual description, packaging,
- Details of approved counties and countries that have withdrawn themselves. etc
It is a legal document issued by any individual, organisation, or agency to not object to the matter mentioned in the certificate.
A special code or neutral code needs approval by CDSCO. It is required when the manufacturer does want its name and address to reflect on the label. To get approval for a special code for the finished formulation or bulk manufacturer need to apply to getting code.
Documents required for applying a special or neutral code:
- Duly signed application for drug export NOC on the Company‘s Letter Head.
- Copy of valid Export Order specifying the name and the quantity of the drug to be exported.
- Letter from overseas buyer specifying the requirement of special code number.
- Copy of NOC for Export issued by State Licensing Authority for specific product packing material, including labels, leaflets, foils, cartons etc, specifying the special code.
- A valid copy of the Registration certificate issued by the Ministry of Health of importing country is to be provided.
A duly attested and valid copy of Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B or its renewal in Form 21C issued to the manufacturer or its agent by the State Licensing Authority in India.
Only registered pharmaceutical companies can export medicines from India as per our Foreign Trade Policy. First and foremost, the company must register with the Director-General of Foreign Trade and apply for an Import Export Code.