During any Import or Export, if any Importing or Exporting good contains medical-related products, then such goods need to obtain no objection certificate (NOC) from the Drug controller office of government, or any such competent body, which is authorized to manufacture those medical-related products. No Objection Certificate is an approval given to the Manufacturer of the medical related product which can be authorized by government agencies of the manufacturing country. It is mandatory for the Pharmaceutical and Medicine related product manufacturers to obtain ADC NOC for Import or NOC from such competent authority of the exporting country.
ADC NOC for Import – Meaning
NOC or No Objection Certificate is a document that is required in many official platforms to signify that there is no objection in the contract or the certificate. The official platforms can be in the form of Government offices, Schools, Colleges, Businesses, Banks, Companies or even Individuals. ADC NOC for Import is required for the Import of certain medal devices to ensure the quality and safety of the products and to make sure that the customers are getting a safe and certified product from outside sources. Different countries have their own policy of Import or Export of products, also known as Foreign Trade policy, which regulates Imports and Exports of various products and ensures their safety and standards. There are various boards in each country that governs and regulates Import and Export. Drugs Controller General of India (DCGI) is the Head of the Central Drugs Standard Control Organization of the Government of India, and is responsible for the approval of licences of notified drugs or medicine-related products in India.
Rules related to ADC NOC for Import
The Central Drug Standard Control Organization (CDSCO) has set up new regulations to get Clarification on the Medical Device regulatory Status. In order to get the Clarification, the Manufacturer needs to submit a No Objection certificate or ADC NOC for Import. It is required to submit a hard copy of the NOC to the Medical Device Division in CDSCO.
There are many drugs and medicine-related products that are manufactured or produced in a limited area or by one Manufacturer. It is possible that only one country or Manufacturer might hold the license to manufacture those products. In such a case, a single manufacturer might need to export the drugs or medical-related products throughout the world. For the Import of such products, it is important to obtain NOC from the regulating body of the country. For India, that regulatory body is CDSCO. CDSCO makes sure that there are clinical trials and quality and standards checks of imported goods. It also coordinates with the State Drug Organization, which looks after the manufacturing, selling, testing, inspecting and marketing of drugs and medical-related products.
There is also a set of rules related to the export of drugs from India and set guidelines for the export of drugs issued by the Central Government’s Ministry of Health and Family Welfare which all the Indian manufacturers must comply with.
Laws governing the ADC NOC for the Import of drugs
The laws governing the ADC NOC for Import, Export, Tests, Trials and sales of Drugs and medicine related products in India are:
- Drugs and Cosmetics Act,1940
- Drugs and Cosmetics Rules, 1945
- Narcotic and Psychotropic Substances Act,1985
- Medicinal and Toilet Preparation Act,1956
- Drugs and Magic Remedies Act,1994
Applicants who are eligible to obtain ADC NOC for Import
Applicants who can get ADC NOC for Import are as follows:
- Indian Agents
- Foreign Enterprises holding Indian Subsidiary
Products considered as Medical Devices
There are a few products which are considered as Medical devices that are regulated by the Drugs and Cosmetics Act 1940. The products listed below require to be registered with CDSCO. There is a specified list of Notified medical devices in India, and only the notified medical devices need to be regulated under CDSCO. Following are some of the medical devices that require registration. But in case where the foreign manufacturers are unaware or unsure about the regulatory status of Medical devices in India, it is essential to get a No objection certificate or ADC NOC for Import of drugs or medical related products. CDSCO will then review the product details and all the related documents, and after assessment, CDSCO will then issue a written statement on the regulatory status of the product in India, and issue a no objection certificate if required. It takes over 4 to 12 weeks for CDSCO to issue No objection certificate after assessing all the relevant information about the product.
The Central Drugs Standard Control Organisation (CDSCO) works under Directorate General of Health Services, Ministry of Health & Family Welfare, under Government of India is the National Regulatory Authority (NRA) of India. The Central Government, through CDSCO exercises regulatory control over the Import or Export of Drugs in India, which is headed by the (DCG) Drugs Controller General of India. The manufacturing, sale, Import and Export of drugs are primarily regulated by the State Drug Control Authorities, authorized by the State Government. The reason behind the drug regulatory system in the country is to make sure that the people are getting safe, certified and high quality drugs and medical related devices to ensure the best possible outputs.
Read our Article:CDSCO Certificate for Drugs Import to India: An Overview