Licensing Process and Rules Related to Phytopharmaceutical Drugs in India

  • 4th September, 2018
Phytopharmaceutical Drugs and Their Related Regulations in India

Now when you know about what is a new phytopharmaceutical drug, now you must be thinking about how and from where to obtain permission either for its import or manufacture?

For importing or manufacturing a new phytopharmaceutical drug in India, one needs to apply for a license. For obtaining permission you have to apply on form 44 for Import Registration & Marketing Authorization as prescribed in D&C Rules.
This application should be sent to the Drugs Controller General (India), Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, along with the R&D data, CMC data, Non-Clinical & Clinical Data for scrutiny.


Along with the application, the applicant has to submit all the documents that have been specified in Appendix IB of schedule Y of D&C rules. The complete checklist can be obtained from CDSCO website. All the prima facie should be sent to the drugs controller via post or can be submitted directly. Meanwhile, extensive efforts are being made on the government’s end for making this process online. Until it is made the manufacturers or the stakeholders have to obtain permission by the above-written process.


After the application is received by CDSCO and initial screening is made, it will be acknowledged. But every applicant must give prior attention while submitting the documents.


You must be thinking what is the necessary conventional preclinical study and safety document that is needed for submission along with the application for a new phytopharmaceutical drug. Well! it all depends on the disease, the nature of the phytopharmaceutical drug and the time it will take to completely heal the disease & the most important is benefit to risk ratio. Accordingly, the applicant has to submit the documents for proper establishment of the safety and effectiveness of the phytopharmaceutical drug.


Rules Related To Phytopharmaceutical Drugs in India:

There are certain rules that are required for regulation of phytopharmaceutical drugs in India. Like parenteral dosage from the drug can’t be taken into consideration for proper market authorization.


Whether it will be sold with or without prescription will be solely decided by CDSCO. Coming to the current GMP requirements for the manufacture of phytopharmaceutical drugs, they are clearly described in the schedule M of the D&C rules but at present, there are no specialized guidelines that are required for phytopharmaceutical drugs GMP.


It all depends on the ingredients and the processing stage. In a chain, common GMP requirements are implemented which are as follows:

  • Cultivation /collection/drying/ minimal processing/ storage and transport of the raw herb.
  • Grinding/extraction/fractional steps/other operations like spray drying/tray drying/packing and storage of the botanical process.
  • The formulation based on compatibility with excipients/ dosage form choose from product formulation/different steps involved in the manufacture.


Moreover, it is expected that this section will be developed more in the coming future and the applicants are advised to adopt a process that will prohibit contamination, destruction and helps in protecting the quality and veracity of the final product.


Thus, from this article, we can get an overall idea on what is phytopharmaceutical drug and what are the rules to be followed for its manufacture, import, export and other regulations.Rest all the other queries popping up in your mind can be resolved when you will refer the FAQ’s on phytopharmaceutical released by CDSCO.