Marketing, Manufacturing, Packaging & Labelling, Advertising
An essential legal guide to marketing, manufacturing, packaging & labelling and advertising in Indian pharma. 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 is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
For information on the marketing authorization process for new drugs, investigational medical devices and new IVDs, please refer Question 3 in the Regulatory, Reimbursement and Pricing Overview for definition
The import, manufacture and sale of drugs (both prescription and non-prescription) and notified medical devices require a license from the CDSCO or SLA, as the case may be.
2. What is the authorization process for the marketing of generic versions of these products?
Marketing authorizations are only required for new drugs, new In Vitro Diagnostic devices (“IVD”) and investigational medical devices. Generic versions of drugs and medical devices require a license for manufacture, import and sale from the CDSCO or SLA, as the case may be.
3. What are the typical fees for marketing approval?
For information on the fee for marketing approval please see Question 4 in the Regulatory, Reimbursement and Pricing Overview for definition
4. What is the period of authorization and the renewal process?
Marketing authorizations are valid in perpetuity. However, for a period of four years from the date of a marketing authorization issued for a new drug, subsequent applicants for the manufacture, import and sale of the new drug is also required to apply for marketing authorization. Upon expiry of the four-year period, the drug can be manufactured, imported and sold with a license from the CDSCO or SLA, as the case may be, without a marketing authorization. For more information on the definition of a ‘new drug’ see Question 3 in the Regulatory, Reimbursement and Pricing Overview for definition.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Subsequent to the approval of a new drug, the applicant is required to furnish Periodic Safety Update Reports (PSUR) to report all the relevant new information, summarize status of market authorization in different countries and to indicate whether changes should be made to product information to optimize use. From the day of receipt of marketing permission, the PSUR must be submitted every six months for the first two years and then once a year for the remaining two years. If any serious adverse events occur post marketing, details of the event must be furnished to the authority within 15 days.
6. Are foreign marketing authorizations recognized?
A drug whose safety and efficacy is not established on the Indian population is considered to be a new drug, irrespective of whether the drug has received foreign marketing authorizations or not. For drugs discovered outside India that have been granted foreign marketing authorizations, Phase I clinical trials need not be conducted locally and the relevant data from foreign trials may be submitted but Phase II and Phase III clinical trials must be conducted in India to obtain marketing authorization. Additionally, if a drug has been marketed in foreign countries for a few years and there is adequate published evidence with respect to its safety, the DCGI may also relax or modify submission requirements.
The rules governing notified medical devices are different in this aspect. Devices which have been granted a free sale certificate in Australia, Canada, Japan, the European Union and the United States of America can be imported without carrying out a clinical trial on Indian population. Permission to import or manufacture devices medical devices without a predicate device can also be granted without providing results of clinical investigations if the device has been marketed for at least two years in the abovementioned countries.
7. Are parallel imports of medicines or devices allowed?
Parallel imports are permissible in India under the Patents Act as well as the Trademarks Act. India follows the principle of ‘international exhaustion’ i.e. if the first sale has been made validly either by the patent holder or someone authorized by such patent holder, the patent holder cannot control the conditions of a subsequent sale or profit from such sale. The same principle applies to trademarks as well. In cases where the goods were acquired legally or were placed on a worldwide market by the trademark owner. However, the imported may be required to communicate to the buyer that the goods are imported. The principle of international exhaustion will not apply in cases the goods were either not lawfully acquired or were changed or materially altered after their acquisition.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 (“MCI Code”) and the Revised Dentists (Code of Ethics) Regulations 2014 (“DCI Code”) regulate the interaction of medical and dental practitioners respectively with pharmaceutical, medical device and allied healthcare companies. The MCI Code and DCI Code prohibit medical and dental practitioners from:
- Accepting gifts;
- Accepting travel facilities from pharmaceutical and allied healthcare companies for attending conferences, seminars, workshops and so on as a delegate;
- Accepting hospitality from pharmaceutical and allied healthcare companies under any pretext;
- Accept any cash or monetary grants from pharmaceutical and allied healthcare companies in an individual capacity.
However, both the MCI Code and the DCI Code permit medical and dental practitioners to be engaged by pharmaceutical and allied healthcare companies as a consultant, researcher or in another professional capacity.
Apart from the restrictions placed on medical and dental practitioners under the above regulations, the Central Civil Services (Conduct) Rules 1964 and similar state-level rules requires that medical practitioners who are government servants cannot place themselves under any financial or other obligation to any individual or organization that may influence them in the performance of their official duties.
In the same way, the Uniform Code of Pharmaceutical Marketing Practices (“UCPMP”) prohibits medical device and pharmaceutical companies from:
- Accepting gifts, pecuniary advantages or benefits in kind;
- Providing travel facilities to healthcare practitioners for attending conferences, seminars, workshops and so on as a delegate.
- Providing hospitality to healthcare practitioners under any pretext.
- Providing any cash or monetary grants to healthcare practitioners in an individual capacity.
However, the UCPMP is currently a voluntary code and does not have the force of law. The Government is reportedly planning to make the UCPMP mandatory in some form of legislation.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
A license to manufacture drugs must be obtained from the SLA of the state where the manufacturing facilities are located. A separate license must be obtained for each plant. In case of certain drugs and medical devices such as new drugs and investigational medical devices, a license from both SLA and CDSCO, as the case may be, is required. If drugs are sought to be manufactured for use in a clinical trial, then a separate license to manufacture for test purposes must be obtained from SLA. For manufacturing a ‘new drugs’ (see Question 3 in the Regulatory, Reimbursement and Pricing Overview for definition), a marketing authorization needs to be obtained from the CDSCO after completion of clinical trials prior to applying for a manufacturing license.
With respect to license for manufacturing notified medical devices, it depends on the risk classification of notified medical devices. Notified medical devices are divided into Class A to Class D in terms of increasing risk. A license to manufacture a Class A or Class B device is given by the state licensing authorities while a license to manufacture Class C or Class D devices will be given by the CDSCO. A separate license must be obtained for each manufacturing plant. If a notified medical device is sought to be manufactured for use in a clinical trial, then a separate license to manufacture for test purposes must be obtained.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
India has independent Good Manufacturing Practices (GMPs), which have been prescribed under Schedules M, M-II and M-III of the D&C Rules. India also has a separate set of GMPs that apply to Ayurveda, Siddha and Unani medicines.
The standards for manufacturing for medical devices have been prescribed in the Quality Management System (“QMS”) in the MDR. They lay down requirements for documentation, management responsibilities, resource management and monitoring. Violation of QMS can lead to cancellation of license.
11. What is the inspection regime for manufacturing facilities?
An inspection of the manufacturing facilities is mandatorily carried out before grant of license. The foreign manufacturing facilities may or may not be inspected, at the discretion of the DCGI prior to grant of license. After grant of license, manufacturing facilities may be inspected by DCGI, State Licensing Authorities at any point without prior notice. If the manufacturing facilities are in violation of the law, a show cause notice is issued to the company and an opportunity for hearing is provided before arriving at a decision.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes, domestic manufacturing facilities are open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA provided the manufacturer has applied for registration of the manufacturing facility before foreign authorities or has already registered the manufacturing facility with the foreign authorities.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
A license must be obtained to stock drugs and a separate license is required for each of the premises where the drug is stored. The storage premises should be adequate in size and should be equipped with proper storage and accommodation for preserving the properties of the drugs. A person who has prescribed qualifications and is competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs must always be present on the storage premise.
Stocks which have expired should not be stored along with stocks which are yet to expire. Storage handling and packaging requirements for different types of products has been specified differently. Storage specifications for vaccines, human blood and umbilical cord blood have been specified in the D&C Act. The CDSCO has also come out with Good Distribution Practices, which, although voluntary, provide guidelines for the storage, packing and transport of drugs.
14. What information must be included in medicine and device labeling?
The following must be included in the labelling:
- Date of manufacture
- Date of expiry.
- Name, address and license details of manufacturer
- Batch or lot number
- Net content in terms of weight, measure, volume, number of units of contents, number of units of activity
- The content of active ingredients.
The generic name of the drug must be printed in double the font size of the brand name or in cases of drugs in the Indian Pharmacopoeia or the National Formulary of India then the name as specified therein.
The labelling requirements also specify that the prescription drugs must have the symbol Rx on them. Other drugs must include the warning that the drug must be taken under medical supervision. The CDSCO continues to update labelling norms through notifications.
The following particulars must be on the medical device:
- name of the medical device
- the details necessary for the user to identify the device and its use
- name of manufacturer and address of manufacturing premises where the device has been manufactured
- statement as to the net contents (in terms of weight or measure)
- license number, date of manufacture
- date of expiry (alternatively, its shelf life)
- applicable storing and handling conditions, warnings and precautions
- the batch number, as well as the manufacturing license number under which it is manufactured (if manufactured in India).
Imported products must display the import license number, name and address of the importer, address of the actual manufacturing premises and the date of manufacture.
The Legal Metrology (Packaged Commodities) Rules, 2011 (“LM Rules”) apply to medical devices that are not currently regulated under the D&C Act. The LM Rules have prescribed labeling and packaging requirements. The label of any commodity covered by the LM Rules are required to have the following declarations:
- Maximum retail price (“MRP”);
- Name and address of the manufacturer or importer;
- Net quantity,
- Common or generic name of the commodity;
- Country of origin;
- Month and year in which the commodity is manufactured or packed or imported;
- Name, address, telephone number, e-mail address of the person who can be or the office which can be contacted, in case of consumer complaints;
- Actual corporate name and complete address of domestic manufacturer or importer or packer;
15. What additional information may be included in labeling and packaging?
Provided the mandatory declarations are made on the label/package and the information is not prohibited under applicable law, any additional information as required by the manufacturer is permitted to be included.
16. What items may not be included in labeling and packaging?
The same restrictions that are applicable to advertisement of drugs and med- ical devices apply to the label and package of drugs/medical devices as well, as claims made on the label or package are considered to be advertisements under the DMRA.
Please refer to Chapter 3 Question 38 for information on restrictions applicable to advertisements of drugs and medical devices.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
There are multiple provisions in the D&C Rules as well as the DMR Act relating to the advertisement of drugs.
- Prescription Drugs (Schedule H and H1) and Psychotropic substances (Schedule X) cannot be advertised without the previous sanction of the Central Government. However, this rule is only applicable to manufacturers.
- Drugs purporting to prevent or cure diseased and ailments mentioned in Schedule J of the D&C Rules such as blindness, baldness, asthma, cancer, obesity and sexual impotence cannot be advertised.
- The DMR Act prohibits advertisement of drugs in a manner suggesting that such drugs may be used for
- the procurement of miscarriage in women or prevention of conception in women
- the maintenance or improvement of the capacity of human beings for sexual pleasure
- the correction of menstrual disorder in women
- curing or preventing any illness specified in the Schedule to the DMR Act.
The Government may, however, advertise a drug in exercise of its discretion. Additionally, drugs may be advertised to a registered medical practitioner in a confidential manner. The document containing the advertisement must bear a prominent message at the top stating “For the use only of registered medical practitioners or a hospital or a laboratory”.
Apart from the rules provisions mentioned above, advertising in India is self-regulated as there is no central authority to monitor or approve advertisements. The Advertising Standards Council of India (“ASCI”), a non-profit organizations comprising media, advertising agencies, advertisers, has published a code regulating the publishing of advertisements in India. The ASCI Code applies to advertisements relating to drugs as well.
The UCPMP, a voluntary opt-in guideline issued by the Department of Pharmaceuticals, also has directions on what promotional materials should contain. The directions are as follows:
- The name of the drug
- name and address of the authorization holder
- Recommended dosage and route of administration
- Adverse reactions and relevant contraindications.
The UCPMP also states that any promotions arranged in journals by pharmaceutical companies must be marked as such and should not appear to be editorial in nature.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Licenses issued for the retail sale of drugs and notified medical devices are premise specific. Therefore, medicines and notified medical devices can only be sold from registered pharmacies, by registered pharmacists. Further, the PPR states that drugs must be dispensed by a registered pharmacist to the patient or the caretaker of such patient directly. Therefore, it is challenging to sell or deliver medicines and notified medical devices via post.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
There are currently no specific laws to governing advertising of drugs over the internet. The same regulatory framework that applies to advertisement of drugs generally will apply to advertising over the internet as well.
However, the government is reportedly in the process of amending the D&C Rules in order to incorporate specific requirements for the online sale of drugs. For more information, please refer to Question 1 of the Regulatory Reform overview.
20. May medicines and devices be advertised or sold directly to consumers?
Medicines and devices that are covered under the advertisement restrictions specified under the DMRA and the D&C Act, cannot be advertised directly to consumers. For details, please refer to Question 38 above.
With respect to sale, pharmaceutical companies cannot sell medicines directly to consumers unless it possesses a retail license. Retail licenses are pro- vided to pharmacies which have been set up in accordance with the require- ments prescribed under the D&C Rules.
21. How is compliance monitored?
The SLAs (and CDSCO, in certain cases) are tasked with monitoring of certain compliances. Inspectors appointed by SLA have powers to enter and search premises when there may be reason to believe that an offence under relevant law has been committed. The Inspector also has the power to seize a violating advertisement or examine a record or document to obtain evidence for the same.
22. What are the potential penalties for noncompliance?
Advertising a drug in contravention of the DMR Act or the D&C Rules may be punishable with imprisonment or fine. On a first conviction, the person may be punished with imprisonment up to six months or with fine or both. For a subsequent offence, imprisonment may extend up to one year with or without fine. Contraventions relating to non-compliance with a condition prescribed in a license (manufacture, import or marketing authorization) may also lead to the cancellation or suspension of the license by the relevant authority.