Drug Export NOC

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.

1. The drug export application must provide a valid export order, and NOC will be issued against each order on a case-to-case basis.
2. 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.
3. 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.
4. Consignment information dispatched, stock remaining, raw material, and intermediates must be made available for inspection by the appropriate authority.
5. The applicant for NOC must prove that there will be physical destruction of all leftover drugs meant for export only.
6. 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.
7. The applicant must also submit all essential Documents in Common Submission Format for issuance of NOC.

Documents Required for Drug Export NOC

The following Documents must be submitted in prescribed the issue of obtaining NOC for exporting Drugs outside India.

Covering Letter

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.

Purchase Order

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.

Manufacturing License

The copy of the licence issued by the competent authority to manufacture drugs for export must be enclosed with the application. Performa Invoice.

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.

Registration Certificate

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.

• Aadhar Card;
• Residence Proof;
• Age Proof;
• Bank account details of the applicant such as account number, bank branch, and IFSC or RTGS Number;
• Details of dependents & employer’s certificate of working for 90 days as construction worker & nomination form.

Why corpbiz?

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