- 1. Registrations and licensing compliances for all pharmacies and sellers of healthcare devices
1. Registrations and licensing compliances for all pharmacies and sellers of healthcare devices
A. LM Act
1.1 Licensing or Registration Requirement
Any individual, firm, society, company, corporation, or Hindu Undivided Family that pre-packs or imports any pre-packaged commodity for sale, distribution, or delivery is required to register itself under the LM Act with the Director or Controller of Legal Metrology. This registration must be completed within 90 days of starting such activities. Depending on the nature of the activity undertaken by the Network Participant or seller, registration under the LM Act may be required.
1.2 Packaging and Labelling Requirements
Entities must ensure that all pre-packaged products display the following mandatory declarations in accordance with PC Rules:
Name and address of the manufacturer, packer, or importer
Common or generic name of the product
Net quantity (weight, measure, or number)
Maximum retail price (inclusive of all taxes)
Month and year of manufacture or packing
‘Best before’ or ‘Use by’ date must be mentioned where applicable
Consumer care contact details
Unit sale price (where applicable)
Country of origin
Mandatory indicators for vegetarian/non-vegetarian origin (where applicable)
Special labelling for GM foods (where applicable)
Where the sizes of the commodity contained in the package are relevant, the dimensions of the commodity contained in the package and if the dimensions of the different pieces are different, the dimensions of each such different piece
Notably, e-commerce entities must ensure that all mandatory declarations (except the month and year of manufacture or packing) are displayed on the digital or electronic platform used for selling the goods. As per the PC Rules, in marketplace models, the responsibility for the correctness of these declarations lies with the manufacturer, seller, dealer, or importer, as applicable.
The packaging and labelling requirements provided under Annexure B (under the head “Packaging and Labelling Requirements”) shall be complied with. However, for the purpose of packages containing food articles, further reference shall be made to Para 1.1 and 1.2 of Annexure B.
1.3 Other compliances under Legal Metrology (Packaged Commodities) Rules 2011 (“PC Rules”):
Other compliance under PC Rules namely, declaration on container type commodities, general guidelines, manner of declaration, and maximum permissible errors on net quantities declared by weight or volume have been discussed in Annexure B.
B. BIS Act
2.1 Licensing / Certificate of conformity and labelling
Please refer to 1.4 of Annexure – C to check the applicability of BIS laws on the subject product(s). Additionally, the labelling requirements have been provided in Annexure – C (under the heading “Labelling requirements”).
C. Import and Export laws
3.1 Registration
Every importer and / or exporter is required to obtain IEC as discussed under the heading below of Annexure - D.
D. Consumer Protection Act and the rules/ guidelines issued thereunder
4.1 Compliances of manufacturer, product service provider and product seller under the CPA
A manufacturer, product service provider and product seller shall comply with the obligations provided under Section 84, 85 and 86 of the CPA.
4.2 Compliances under E-commerce Rules
(i) Please refer to Para 1.1 of Annexure E for compliances to be followed by all E-commerce entities.
(ii) Please refer to Para 1.2 of Annexure E for additional compliances to be followed by all marketplace E-commerce entities.
(iii) Please refer to Para 1.3 of Annexure E for additional compliances to be followed by all inventory E-commerce entities.
(iv) Please refer to Para 1.4 of Annexure E for additional compliances to be followed by all sellers on the marketplace E-commerce entity.
4.3 Guidelines on Misleading Advertisements
Please refer to Annexure F for the compliances to be followed under these guidelines by an entity advertising goods or services offered by it to consumers.
4.4 Guidelines on Dark Patterns
An entity advertising goods or services offered by it to consumers must comply with the Guidelines on Dark Patterns.
4.5 Greenwashing Guidelines
Please refer to Annexure G for the compliances to be followed under these guidelines by an entity advertising goods or services offered by it to consumers.
E. Data protection laws
The IT Act read with the SPDI Rules are the primary legislations in India governing data privacy and protection on a sector-neutral basis. To the extent the NPs will collect/handle personal data falling under the category of SPDI, it is required to be compliant with the obligations specified under the SPDI Rules. A summary of the key obligations under the SPDI Rules of an entity, inter alia, for collecting, processing and transferring of SPDI, has been set out in Annexure H.
Please note that once the DPDP Act is enforced, all entities collecting, handling, or processing personal data will be required to comply with the obligations prescribed under the DPDP Act.
F. Compliance with IT Rules
To the extent, the NP qualifies as an intermediary, it will be required to implement the due diligence obligations (depending on the category of intermediary) as has been set out in Annexure I, if it seeks to avail the exemption from liability in accordance with Section 79 of the IT Act.
G. Compliance with drugs, cosmetics and medical devices laws
7.1 Licensing Requirements
(i) Please refer to Para 1.1 of Annexure J for the license required for retail sale of Drugs under the Drugs Rules.
(ii) Please refer to Para 1.2 of Annexure J for the license required for wholesale sale of Drugs under the Drugs Rules.
(iii) Please refer to Para 1.3 of Annexure J for the license required for import license under the Drugs Rules.
(iv) Please refer to Para 1.4 of Annexure J for the restricted license under the Drugs Rules.
(v) Please refer to Para 1.5 of Annexure J for the license required for selling homeopathic medicine under the Drugs Rules.
(vi) Please refer to Para 1.6 of Annexure J for the license required for manufacturer, importer, seller of medical devices under the Medical Devices Rules.
(vii) Please refer to Para 1.7 of Annexure J for the license required for importing cosmetics under the Cosmetics Rules.
7.2 Packaging and labelling requirements
(i) Depending on the category of Drug, the relevant NP is required to adhere to the packaging and labelling requirements as provided in Para 2.1 of Annexure J.
(ii) Depending on the nature of the medical device, the relevant NP is required to adhere to the packaging and labelling requirements as provided in Para 2.2 of Annexure J.
(iii) The packaging and labelling requirements of the cosmetic products must be in compliance with Chapter VI of the Cosmetics Rules.
H. Compliance with Pharmacy Act
8.1 Licensing and other requirements
Every pharmacy is required to be under the supervision of a pharmacist who is registered with the relevant State’s Pharmacy Councils in compliance with the Pharmacy Act. Additionally, a pharmacy and the pharmacist is required to comply with the provisions of the Pharmacy Act read with the Pharmacy Practice Regulations 2015 which includes the manner of maintaining prescription register, qualification of pharmacist, duties and responsibilities of a registered pharmacists etc.