The clinical trials industry — which analysts have previously dubbed as the 'sunshine sector' and perceived as a potentially upcoming segment — is at a crossroads today. Among its many challenges is the lack of a standardized and balanced regulatory structure, along with an increasing number of datacompromise allegations. Clinical-trial approvals have faced significant delays, which has led to a scenario where the very future of the industry is now uncertain 1.
Various factors contribute to this uncertainty. For instance, the Drug Controller General of India (DCGI) usually takes 12 to 16 weeks to approve trials as against six to eight weeks in the US1. The industry is also becoming progressively competitive, with countries such as China, Korea and Singapore emerging as fierce competitors. Meanwhile, MNCs are reportedly lowering their budgets while focusing on bringing drugs to the market quickly. Manufacturing is becoming the key focus of most companies, and CROs (especially CMOs) could benefit from this development. The decline in clinical trials in the US has led to an increase in trials across emerging countries.
While India holds a market share of 2.20 percent, China accounts for 2.83 percent. Between 2008 and 2009, the Indian clinical research market registered a 9.60 percent decline in revenues, while China's grew by 15.30 percent. India is yet to recover from this decline; the decreasing number of clinical trial approvals in 2011 has further compounded the situation 2.
Currently, the Indian Council of Medical Research (ICMR)’s and the office of the DCGI’s guidelines govern clinical trials in India. In 2005, India amended Schedule Y of the Drugs and Cosmetics Act to create an environment conducive to conducting trials; however, concrete laws are yet to be introduced in this regard 3. It is now a regulatory mandate that a drug can be launched in India only if its trial is conducted in the country. This is a potential concern for MNCs due to the complexities involved in the international launch of drugs.
Thus, a meticulous regulatory framework for clinical trials is imperative in India. Otherwise, countries with strict regulations and supervision on adherence are likely to have an edge over the country.
India’s credibility as an outsourcing destination has been a matter of global speculation. Institutional Ethics Committees (IECs) primarily oversee the ethical execution of a clinical trial in the country at present. IECs are decentralized, and no independent authority for their management exists. Such factors have hampered India’s credibility as an ethical site to conduct clinical trials 4.
Further, data compromise and breach of confidentiality allegations have plagued Indian CROs. Data protection has always been a concern, considering India’s weak intellectual property structure; however, allegations of data compromise and fraud have only added fuel to the fire.
Another important mechanism for overseeing GCP guideline compliance is the process of clinical trials auditing. It is considered mandatory in the EU and by the US Food and Drug Administration (FDA). However, the Indian Drug Law merely states that an audit certificate should be included in a new drug dossier “if available” 5.
Impact on the industry
Regulatory and ethical challenges are among the many challenges that
continue to hamper the growth of the Indian clinical trials industry. Lack of skilled technicians, competence in various other therapeutic areas (India’s domain knowledge is primarily in oncology and cardiovascular treatment) and lack of adequate infrastructure are other issues that require immediate attention. A key requirement is the need to heighten awareness through training and communication.
Amendments in drug laws to make GCP assessments mandatory in dossiers compiled for New Drug Approvals (NDAs) could also help strengthen the regulatory framework. The need for auditing should be understood and appreciated, so that quality assurance makes it easy for a CRO to showcase its strength globally 6.
Without a Fraud Minimization Framework (FMF) in place, the incidence of wilful misconduct cannot be ascertained. Sponsors and regulators have resource limitations to conduct a 100 percent inspection of all trial sites. An independent agency which can design such a framework and implement it would help the industry gain the credibility that it currently lacks 6. At every level — the sponsor, monitor, regulator, inspector, investigator, clinical coordinator — there should be a clear focus on integrity and quality for India’s clinical trials industry to flourish.
1. KPMG in India Analysis
2. “India is trailing China”- Biospectrum – 11 May 2012
3. ICMR Guidelines
4. WHO guidelines
5. “India is trailing China”- Biospectrum – 11 May 2012
6. KPMG in India Analysis