Labels and labeling materials are the main sources of information for consumers since they include valuable details on the safe and reliable use of a drug product (such as indications, pharmacologic class, and dose), as well as details about quality. An essential component of the pharmaceutical sector is effective packaging. During storage, selling, delivery, and use, it safeguards the medication. Pharmaceutical items are packaged differently depending on the type of drug since they may interact with one another.Then the process of importing the medicines and medical devices plays a major role in bringing them into the market. For ensuring the proper functioning of medicines and medical devices, it is necessary to comply with the labeling, packaging, and importation requirements provided under the law. The following are the provisional requirements for the process of labeling, packaging and importation of medicines and medical devices, which includes;
- Labeling Provisions and Requirements
For medical devices:As per Section 109-A of the Drugs and Cosmetics rules, 1945 every medical device in practice in India should be labelled according to the Indian standard specifications laid down by the Bureau of Indian Standards and also must be inconsistent with any other rules laid down under this provision. The outer covering of the medical device must be labelled which must contain the following information:
- Name of the device, the manufacturer, and the address of the manufacturing premises.
- Details for identification.
- The correct statement of net quantity in terms of weight
- Medicinal or biological indication.
- The lot no. or batch no. along with the manufacturing no. or license no.
- Warnings or precautions for the usage of such devices.
- Single usage indication.
- Clinical investigation label.
- Indication of using the device as a free sample for medical device.
- In-vitro diagnostics indication.
- Any other symbols as may be recognized by the Indian standard of specifications.
For Medicines: For the purpose of labeling the drugs as per Section 96 of the Drugs and Cosmetics Rules, 1945 it is essential to print the following information on the label of the drug:
- Name of the drugs.
- A correct statement of the net content in terms of weight, measure, volume and number of units.
- The content of the active ingredients.
- Name of the manufacturer and the address of the manufacturing premises.
- A distinctive batch number.
- Packaging Requirements
The proper packaging of medicines and medical products is very much essential to manage all the aspects of quality of the medicines. The following are the packaging requirements:
- Containment of the ingredients.
- Selection of proper packaging material for maintaining stability.
- Protecting the main pharmaceutical product from external factor
- Effective storage must be made while packing.
- Importation Requirements
For the purpose of importation of medicines and medical devices, the following particulars are essential:
- Sale or distribution license obtained by the foreign manufacturers and the local authorized agents.
- Covering Letter.
- Power of attorney
- Application form
- Copy of import permission
- Authorization letter
- Schedule D (I) and (II), an undertaking duly sealed, signed and stamped by the manufacturer or his authorized agent or the Indian agent.
- Free sale certificate
- Manufacturing License & Market authorization Certificate
- Establishment License
- Inspection or Audit Report
- An Undertaking from the proprietor of the firm (in the case of proprietorship firm)
- An Undertaking from the Board of Directors (BoDs) (in case of a Private Limited Company)
The evidence of the accuracy of scientific content related to the drug can be made only when there is proper compliance with their statutory requirements. There should be strict enforcement of laws related to labeling content and format of prescribed drugs, packaging of such drugs, and other importation regulations for better and safer use of medicines. While for other products these requirements indicate a procedural necessity alone but for pharmaceutical products, these requirements form a crucial element both from the provider as well as user point of view. Hence compliance to these requirements is essential for the labeling, packaging and importation of medicines and medical devices.
Intern at Aggarwals & Associates, S.A.S. Nagar, Mohali