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Mandatory Documents to be submitted for import of ayurvedic drugs

INTRODUCTION
In India, the regulatory framework for Ayurvedic drugs has remained unclear, as the forms prescribed under the Drugs Rules, 1945 (“Drugs Rules”) for obtaining an import license are not appropriate for Ayurvedic drugs.
The Madras High Court in the case of M/s Axeon Marketing India v. Assistant Commissioner of Customs has clarified the steps to be followed for the import of Ayurvedic drugs into India.
In this article we have listed the documents required and steps to be followed for the import of ayurvedic drugs into India.

The following are the essential steps to be followed, along with the required documents:

1. Submission of regulatory documents
Despite the absence of specific licensing forms, importers should proceed by compiling a comprehensive documentation to present to Customs authorities and the State Licensing Authority (“SLA”). This should include:
– Copy of invoice
– Packing list which includes the details of contents of each package
– Manufacturer’s test report
– Manufacturing license (from the country of origin)
– Specimen sample
– Label (The label must comply with the labelling requirements given under Rule 161 of the Drugs Rules.)

2. Testing by Central Drugs Standard Control Organization-accredited laboratory (“CDSCO lab”)
It is now mandatory that imported Ayurvedic drugs be tested at a CDSCO lab in India to ensure compliance with Indian safety and quality standards. The imported drug must meet standards equivalent to those applicable to similar Ayurvedic drugs already manufactured and approved in India.
– The importer is required to submit imported drug samples to a CDSCO lab, where testing will be conducted under the supervision of SLA of the state in which the laboratory is located.
– The cost for testing will be borne by the Indian importer
– If a satisfactory report is received from such laboratory, the concerned SLA will issue a certificate confirming that the manufacturing process of the imported drugs is in conformity with the process prescribed for the manufacture of ayurvedic drugs in India.

3. Submission of certificate issues by SLA
– A copy of the certificate issued by the SLA must be submitted to the Customs Department.

4. Receipt of Assistant Drug Controller’s No Objection Certificate (“NOC”)
– This document is issued by the port office of CDSCO.
– The NOC indicates that the consignment meets all applicable regulatory requirements
– Invoice, packing list, manufacture’s test report, manufacturing license, specimen sample, label may be examined before giving NOC by port office.

CONCLUSION
A guidance document governing the import of Ayurvedic drugs already existed, however, it did not mandate testing of the imported drug by a CDSCO lab. After the recent judgment by the Hon’ble Madras High Court, this requirement has now been made compulsory. Therefore, importers must comply with this requirement, along with all other steps outlined above, to obtain import clearance.

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TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.

1. India’s Central Pollution Control Board (CPCB) has directed Plastic Waste Processors (PWPs) to upload valid GST e-Invoices for the sale of product for the purpose of EPR certificate generation on the EPR portal for plastic packaging. The invoices must include key details like Buyer GST number, Seller GST Number, IRN No., HSN code, Invoice Number and QR code, ensuring they are signed, clearly visible, and readable.
Source: bit.ly/4fGikIn

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Source: bit.ly/4iXJrl4

3. India’s Karnataka High Court has temporarily barred government action against pharmaceutical companies manufacturing nutraceuticals in drug-licensed facilities until its next hearing. This follows challenges by industry bodies and stakeholders against Schedule M of the Drugs and Cosmetics Act, which prohibits the production of non-drug items, like nutraceuticals, in drug manufacturing premises.
Source: bit.ly/41WVEQI

4. Doctors in the Indian state of Maharashtra have raised concerns over a directive from the state’s Food and Drugs Control Department (FDA), which allows homeopaths with a modern pharmacology certificate to prescribe allopathic medicines, despite a pending case in the Bombay High Court. They have also questioned the eligibility of homeopaths to prescribe modern medicine. The directive permits chemist retailers and wholesalers in the state to sell allopathic medicines prescribed by such homeopaths.
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5. The Chief Medical and Health Officer (CMHO) of a district in Madhya Pradesh, India, has warned private hospitals against employing BAMS/BHMS doctors as RMOs or duty doctors, particularly in ICUs and emergency departments, instead of qualified MBBS doctors and the violations may lead to registration cancellations under the Nursing Home Act. This comes amid nationwide concerns over patient safety and the misuse of medical designations, with healthcare experts calling for stricter oversight and accountability.
Source: bit.ly/3DOcMhw