The year 2013-14 has been momentous for clinical trial regulations in India. By releasing several official orders and notifications, the Central Drugs Standard Control Organization (CDSCO) in close association with the Ministry of Health and Family Welfare (MOHFW) has shown their commitment and determination towards setting up a safe, effective, more transparent and sustainable regulatory framework in India.

With issuance of the recent draft accreditation standard for clinical trial sites, ethics committees and investigators, the National Accreditation Board for Hospitals and Healthcare Providers (NABH), in co-ordination with Ministry of Health wishes to institute a structured accreditation process to build in quality in the new clinical trials regimen of India. As per Ranjit Roy Chaudhury Committee report, accreditation will be the centerpiece of the new clinical trials regimen founded on the principles of patient safety. It appears to be a well thought move to increase accountability of clinical trials in India and is also expected to give impetus to the clinical trial industry in India, which is currently suffering due to uncertain regulatory environment in India.

Background of accreditation in clinical trials
Accreditation is a process by which the achievements of an organization are recognized publically through an independent external peer assessment of the organization’s level of performance against a set of objective standards.

Accreditation in the field of clinical trials is not a new or a rare concept. It has been in existence since decades as a comprehensive program for the protection of human research participants. The National Committee for Quality Assurance (NCQA) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP), are the two pioneer organizations working towards the common objective of creating quality systems for the accreditation of the “human research participation protection programs” in order to promote excellent, ethically sound research.

In India a total of six organizations (five hospitals and one academic institute) has been accredited by AAHRPP till date. The primary goals of the AAHRPP accreditation are to:
n    Improve the systems that protect the rights and welfare of the research participants
n    Publically communicate the strength of an organization’s commitment to the protection of human research participants

In short the accreditation helps in building trust and confidence among all the stakeholders, patients being the biggest beneficiaries, as it results in high quality of care and patient safety.

NABH draft accreditation standard and accreditation process
The draft accreditation standards for clinical trial were issued by National Accreditation Board for Hospitals and Healthcare Providers (NABH) in January 2015. The accreditation standard released by NABH has been classified into three sections, which have further been divided into standards and their respective objective elements.

Though the standards and the application form for the accreditation has been released, there is still some ambiguity (in terms of the process which will be followed for the accreditation and its maintenance), since the clear mandate or the road map for the same is yet to be released by the NABH.  

The clinical trial accreditation standards when read collectively point towards the better days ahead, as accreditation will promote professionalism and will enhance sustainability and excellence. Accreditation will reduce cost and time required to evaluate promising drug molecules, support regulatory oversight and compliance and will also promote ethical conduct of clinical trial making new, safe medicines available to patients more quickly with improved outcomes.

Since the intent of the clinical trial accreditation standards and the process matches with the elements of effective accreditation devised by Site Accreditation and Standards Initiative (SASI) there is high probability that this process will rejuvenate the entire clinical research industry in India.

Conclusion
The accreditation of investigative sites, ethics committees and investigators will provide credibility and reputation and will show their dedication towards ongoing and continuous compliance with the highest standard of quality

Through the accreditation of the sites, ethics committees and investigators offers several advantages. Its fullest potential lies in the correct implementation and maintenance.

The effective and value-added accreditation will depend on following factors:

• The accreditation of sites, ethics committees and investigators should be independent and voluntary process
• The standards should pay specific attention to continual quality improvement, provide flexibility in achieving the performance goals and should be explicit in their grounding in current regulations
• Clear mandate or road map for the accreditation should be prepared and communicated
• The accreditation program should be management driven, educationally- based model of accreditation
• The initial step in the accreditation process should be self-assessment by the organization seeking accreditation. This will enable the organization to identify and remedy program weakness
• The program should incorporate the annual report submission by the accredited organization to keep NABH informed about any major changes or problems related to the accreditation program
• Since the proprietary information will be reviewed by the third party assessors, it is crucial that strict confidentiality requirements should be laid down and communicated