Pharmaceutical Laws are the laws concerns with the creation, sale, distribution and use of pharmaceutical drugs. In India, the same is governed by a number of legislations, which depends on the usage. The Pharmaceutical industry in India is valued at around 27.4 billion Dollars which include domestic as well as export and import. In India, this industry is basically involved in majorly four sectors i.e., production of branded medicines, generic medicines, unbranded generic medicines as well as production of branded active pharmaceutical ingredients. Furthermore, India is expected to be one of the world’s fastest expanding pharmaceutical marketplaces. Moreover, India is emerging as the most favoured destinations for collaborative Research & Development bioinformatics.
IMPORTANT LAWS AFFECTING THE INDUSTRY
Drugs and Cosmetics Act, 1945 and Rules
- Drugs (including certain medical devices) and cosmetics are regulated in the manufacturing, import, distribution, and sale [confirm].
- Prescribes product and labelling standards
- Regulates clinical trials
- Regulates advertisements of drugs
Pharmacy Act, 1948
- Regulates pharmacy education, profession and practice of pharmacy in India
- Provides that an offense in a professional capacity by a registered pharmacist may lead to penal action under the Act to the extent of permanent deregistration
- Impersonation as a registered pharmacist is also punishable under the Act
The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954
- Regulates advertisements of drugs relating to diagnosis / cure / mitigation / treatment / prevention of certain prescribed diseases and conditions
- Diseases and conditions include AIDS, Asthma, Cancer etc.
Indian Patent Act, 1970
- Provides for product and process patent for 20 years
- Specific provision for compulsory licensing and prevention of ever- greening
Trade Marks Act, 1999
- Grant exclusive use of a registered trademark in connection with certain goods and services in India’s territory.
- The law only protects trademarks that have been registered. For infringement of an unregistered trademark, a passing-off action will be filed.
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 (MCI Code)
- In India, it regulates the professional behaviour of registered medical practitioners
- Prescribes that registered medical practitioners, among other things, will not accept any gift from the pharmaceutical or allied healthcare industry or their sales representatives, and will not publicly support any drug or product
- Makes recommendations to organisations (such as hospitals) about the unethical nature of patient solicitation
- Violation of the MCI Code shall be considered professional misconduct, and will result in a penalty of permanent exclusion from practise, in addition to any other civil or criminal action that may be available under applicable law.
Drugs Price Control Order, 1995 (DPCO)
- Regulates prices of restricted bulk medications and formulas
- Regulates margins offered to dealers and retailers
- Imposes obligation to sell bulk drugs and formulations to dealer (conditionally) and consumer (unconditionally)
Uniform Code for Pharmaceutical Marketing Practices (UCPMP)
- Regulates marketing practices of pharmaceutical industry
- Requires prior permission from the Drugs Controller General of India for promotion
- Requires promotion to be accurate, fair, objective, verifiable and not be misleading
- Establishes standards for competitor product comparison
- Forbids the exchange of gifts in any form
- Voluntary code with a condition that non- compliance will result in conversion to statutory code.
Information Technology Act, 2000 (IT Act)
- Imposes liability on any body corporate or individual dealing with sensitive personal data or information for negligence in implementing and maintaining reasonable security and protocols for the securitization of such data, if such carelessness results in unjust gain or loss to any person.
- Penalizes disclosure of personal information to a third person, if it is done without consent of the person to whom such information belongs or in breach of a lawful contract, and with the intention or knowledge that the disclosure will cause wrongful gain or wrongful loss
- Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011 define sensitive personal data or information to include medical records and history and such personal information relating to physical, physiological and mental health condition
National List of Essential Medicines (NLEM)
- List published by Ministry of Health and Family welfare
- All medicines in the list are deemed essential, and are available or made available at affordable costs and with assured quality
- List comprises of a total of 348 medicines (excluding repetition)
- The last list was published in 2011.
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