Traditional Medicines and OTC Products
A guide to the legal requirements for traditional medicines and OTC products in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Traditional medicines are categorized under the D&C Act broadly into Ayurveda, Siddha and Unani (“ASU”) drugs and Homoeopathic medicines.
AYURVEDA, SIDDHA AND UNANI
ASU drugs are those which are manufactured exclusively in accordance with the formula prescribed in the Ayurveda, Siddha and Unani Tibb systems of medicine as specified in the D&C Act.
The State Licensing Authority is responsible for issuing licensing with respect to manufacture of ASU drugs. A different license must be obtained for each premise Manufacturing facilities must comply with Good Manufacturing Practices (specified in Schedule T of the D&C Act) as a precondition to obtain a license.
It is an offence to manufacture adulterated or spurious ASU drugs or drugs that are not in accordance with prescribed standards. Depending upon the specific offence, the penalty levied ranges from imprisonment between three months to three years and fine between INR 500 to INR 5,000. Subsequent offences of a similar nature carry a greater penalty.
Homoeopathic medicines include drugs which are recorded in Homoeopathic provings and whose therapeutic efficacy has been established through long clinical experience as recorded in the authoritative Homoeopathic literature of India and abroad. It must be prepared according to the techniques of Homoeopathic pharmacy and also includes a combination of drugs.
A New Homoeopathic Medicine (“NHM”) is one which is not specified in the Homoeopathic Pharmacopoeia of India, USA, UK or Germany or not recognized as efficacious in authoritative Homoeopathic literature under the conditions prescribed. A combination of two Homoeopathic drugs not mentioned in authoritative literature is also included.
An import license is required for importing Homoeopathic medicines. A special permission is required from the CDSCO for importing NHMs.
A license needs to be obtained for manufacturing or selling Homoeopathic medicines. If drugs are being manufactured, stocked or sold at more than one place a separate license needs to be obtained for each individual facility. Licenses are valid for a period of five years. Applications are made to the State Licensing Authority for manufacture of Homoeopathic medicines and to the Central Licensing Authority for manufacture of NHMs. Drugs may be manufactured in small quantities for test or analyses if the manufacturer holds the appropriate licenses.
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Traditional drugs can be advertised directly to the public, subject to the restrictions imposed by the DMR Act and the D&C Rules. For restrictions placed the DMR Act and D&C Rules see Question 17 in the Manufacturing, Marketing, Labeling and Packaging overview.
The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (“AYUSH”) has signed a Memorandum of Understanding with the ASCI where they have agreed that ASCI will comprehensively monitor and identify potentially misleading advertisements in the AYUSH Sector and process complaints through its Customer Complaint Council (“CCC”).
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Schedule J of the D&C Act and the DMR Act states that drugs purporting to prevent or cure certain ailments is prohibited. For advertisement restrictions placed by the DMR Act and D&C Act see Question 17 in the Manufacturing, Marketing, Labeling and Packaging overview.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The D&C Act or the Rules do not specifically mention OTC drugs. The two broad categories envisaged by the Act are prescription and non-prescription drugs. Prescription Drugs are those specified in Schedules H, H (1) and X of the D&C Act but there is no specific schedule enlisting the non-prescription drugs. There are certain drugs, however, which can be sold in non-drug licensed stores i.e. in non-pharmacies. These drugs are specified in Schedule K of the D&C Act and include drugs such as quinine and other anti-malarial drugs and household remedies such as Aspirin tablets, Paracetamol and Gripe water.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Non-prescription drugs specified in Schedule K can also be sold in non-pharmacies as there is no license requirement to sell them. Therefore, OTC drugs can be sold through additional locations than other drugs.
6. What health, advertising, and marketing claims may be made for OTC products?
There are no specific advertising regulations for non-prescription drugs and the regulations applicable to drugs generally are applicable. For information on the rules concerning advertising in India see Question 17 in the Manufacturing, Marketing, Labeling and Packaging overview.
7. Can OTC products be marketed or advertised directly to the public?
OTC products as identified in Question 4 above cannot be marketed or advertised directly to the public.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
There is currently no mechanism in place for prescription-to-OTC switches. However, the Central Government has the power to frame rules to give effect to the provisions of the D&C Act. To that end, the Central Government may include or exclude a drug from the relevant schedules thereby changing the degree of regulatory compliance required to manufacture and/or sell the drug.
9. What are the requirements for the importation of either traditional medicines or OTC products?
An import license is required to import homoeopathic medicines and an additional special permission is required from the CDSCO for the import of NHMs. Medicines with less than 60% of their shelf life remaining are not allowed to be imported unless the licensing authority has allowed it in writing. The drugs must also meet the standards of strength, quality and purity that may be prescribed for them. The packaging and labelling requirements applicable to domestically manufactured Homoeopathic Medicines are also applicable to imported drugs.
Drugs whose import is otherwise prohibited may be imported in small quantities for test purposes. The Licensing Authority may inspect the premises where such drugs are stored to ensure they are being used in accordance with the license requirements.
If the Customs Collector has reason to believe that drugs are imported in contravention of the provisions of the Act he may forward them to the Director of a laboratory appointed for this purpose. If the drugs are found to be not of standard quality, the import must either export them back to the country of manufacture or forfeit them to the Central Government to be destroyed.
India also requires the importer to have an Import Export Code (“IEC”) prior to importing any item. The IEC is a ten-digit code issued by the Director General Foreign Trade with a lifetime validity. The customs authorities require an IEC prior to clearing any shipment.
The requirements for importing OTC products is the same as that of other drugs.