GCP for new drug clinical trials in India

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CLINICAL EVALUATION OF HERBAL REMEDIES AND
MEDICINAL PLANTS Some issues
R.Raveendran Chief Editor Indian Journal of
Pharmacology

• GCP for new drug clinical trials in India

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GENERAL CONCERNS

• Herbal remedies and medicinal plants are to be
  clinically evaluated if they are to be used in
  the Allopathic System

• The procedures laid down by the office of the
  Drugs Controller General of India for
  allopathic drugs should be followed

• All the general principles of clinical trials
  described by ICMR Ethical Guidelines pertain
  also to herbal remedies.

• Association of physicians from the concerned
  system is desirable for designing and evaluating
  the study.

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SPECIAL CONCERNS
Three categories of herbal remedies
1. Well known and well described
2. For a new therapeutic effect not
indicated/described New methods of preparation
To be treated as new substance (NCE) and
toxicity data have to be generated as required by
the regulatory authority.

• Compound or extract never been used before or
  described
• To be treated as a new drug and should undergo
  all regulatory requirements.

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SPECIAL CONCERNS

• Herbal remedies currently in use or mentioned in
  literature of recognised Traditional System of
  Medicine is prepared strictly in the same way as
  described in the literature while incorporating
  GMP norms for standardisation

• It may not be necessary to undertake phase I
  studies.

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Toxicity studies

• Since the substance to be tested is already in
  use in Indian Systems of Medicine or has
  been described in their texts, the need for
  testing its toxicity in animals has been
  considerably reduced.

• Toxicity study NOT needed for phase II trial
  unless there are reports suggesting
  toxicity or when the herbal preparation is to be
  used for more than 3 months.

• If toxicity studies are needed, regulatory
  requirements to be followed.

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Some important directives

• Clinical trials with herbal preparations should
  be carried out only after the prescribed
  standards are met.

• The recommendations regarding informed consent,
  inducements for participation, information to be
  provided to the subject, withdrawal from study
  and research involving children or persons with
  diminished autonomy, all apply to trials on plant
  drugs also.

• These trials have also got to be approved by the
  appropriate scientific and ethical committees of
  the concerned Institutes.

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Some important directives contd.

• It is essential that a competent Ayurvedic,
  Siddha or Unani physician is a co-investigator in
  such a clinical trial.

• Commercialization of Folklore medicine/Ethnomedici
  ne - Intellectual Property Rights and / Patents -
  legitimate rights/share of the Tribe or Community

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Thank you