Norms to come into effect from December 1
MUMBAI: The Drug Controller General of India’s (DCGI) decision to implement guidelines for global clinical trials is likely to boost the number of clinical trials in the country. The DCGI is to implement guidelines for global clinical trials in India is from December 1.
Before a drug is launched in the market, the company has to hold pre-clinical trials (animal studies) and phase I, II, III trial in human beings. Phase I and II are being conducted in small number of patients while phase III will be conducted in large pool of patients at multiple sites.
Clinical trials involve almost 70 % of time and money of new drug development. Cost of conducting clinical trials for new drug is approximately between $200-250 million. Due to the fact that the costs are 50-60% lower in India than the trials conducted in developed countries, more MNCs are thronging to India to conduct their trials.
A recent Mckinsey report estimates the global clinical trial outsourcing opportunity in India to be around Rs 5,000 crore by 2010. European and US pharmaceutical companies alone will unleash $1.5 billion per year on clinical trials in India by 2010.
Dr Umakanta Sahoo, general manager, Chiltern International Private Limited, a Mumbai-based CRO, welcomed the decision. “The move will boost the image of the Indian clinical trials industry. It will help to bring more clients as the guidelines will be at par with International guidelines.”
For the purpose of granting permission, the clinical trials are classified into Category A and Category B. Category A will include those clinical trials whose protocols are approved by developed countries including US, UK, Switzerland, Australia, Canada, Germany, South Africa, Japan and European Agency for the Evaluation of Medicinal Products (EMEA).
All applications which are not covered under Category A will fall under category B. Once an application is considered under Category B, it will not be shifted to Category A even though the applicant produces an approval from the developed countries mentioned above the protocols.
As per the rules, the applicant has to submit details like regulatory status of the drug in other countries, including names of countries where the drug is approved, along with international package insert or the place where Investigational New Drug (IND) application is filed. Applicants have to report any Suspected or Unexpected Serious Adverse Reaction (SUSAR) from other participating countries, if any. Further, it is necessary to give an affidavit from the sponsor that the study has not been discontinued in any country. I
In case of discontinuation, the reasons have to be communicated to DCG I. Chemical and pharmaceutical data, generic name and chemical name, dosage form, composition, animal pharmacology and toxicity data, animal toxicology data and clinical data, phase- I, II, III and IV data should be submitted to the DCGI.