Dr Siddharth Dutta, Senior Healthcare Advisor opines on how the general elections will impact the healthcare industry for the foreseeable future
Finally some good news. Hence, let me borrow few lines from singer Graham Nash’s “The Path Tonight”…’So slowly yet so fast, That you can lose your way, To these golden days.’ The new Drugs and Clinical Trials Rules are out in 2019 and are expected to promote clinical research in the country through a transparent process yielding faster approvals. The DCT rule will be applicable to all new drugs, ethics committee and investigational drugs applicable for human use, bioequivalence study (ies) and clinical trial in India.
The change that will impact long term growth of CRO in India
The new rules state that any drug discovered/invented/synthesised in India, or research and development of the drug has been done in India, and which is proposed to be manufactured and marketed in the country, will be deemed approved for clinical trials within 30 working days by Central Licensing Authority (CLA). In the event that there is no communication from the CLA to applicant within the stipulated time, then the permission to conduct clinical trial shall be assumed to have been granted. Again, think about it “So slowly yet so fast”, the policy makers have finally done it. Congratulations!
Readers among you are already aware that the government has removed a clause in the clinical trials rules of India that mandated the sponsor to compensate upto 60 per cent of amount upfront in case of death or permanent disability of a patient (to be paid within 15 days in the event of death during clinical trial). This should be considered as a welcome move for all the subjects participating in clinical trials in India. Earlier there was no clarity and there were long and cumbersome legal hassles which created a question mark on the safety of trials.
Besides the above change, the drug companies considering India as a market for running local clinical trials get additional benefits if the drugs are approved and marketed in the European Union, the UK, Australia, Canada, Japan and the US. The DCGI would now accept the data generated outside the country thereby making the process easier and application time shorter.
It’s a makeover time due to the efforts of the current government and policy makers, considering the not so favourable picture of the clinical trial market in India in the past, things have drastically improved.
(PS: 2018 data was available till Jan-Feb only and rest are estimates based on assumptions and research. Ref: Dr. M V V Rao’s article published in Indian Journal of Pharmacology, 2018 – “Clinical Trial Registry”; Frost and Sullivan; IMS Data, SG Analytics, Stratview Research, medrio.com, outsourcing-pharma.com)
Although the market is optimistic it does not look like that it will have a linear growth rate, unlike claims made by few market research reports that the market will be growing at 12-15 per cent CAGR or more in between 2015 -2025 which are somehow misleading. Based on my research and corroborated with that of several credible market data and considering the total number of clinical trials registered till Q1 2018 in India, the market might grow upto 8.5-9 per cent from 2019-2021 and then may pick up faster (2022-2026 to around >12 per cent, if the rules implemented in 2019, yields results in 2019-20 and saves time and cost for the multinational companies. Foreign companies based out of the US and Europe who have been eyeing China as a trial market are yet to gain confidence and are closely watching the scenario, post the new rule in 2019.
With the US and China fighting out their trade differences in the open, and asking US companies to move out of China (manufacturers), India remains a viable option in 2019. Also considering that the US is adding sanctions in countries all over the market and creating a complex environment for American drug companies to conduct trials, what could be the best bet for pharma giants?
Yes, probably the much talked about red tapism have been taken care for the time being in India. American and European drug companies can include Indian subjects in their multi-field trials and get benefits from the new regulations in India in 2019 and onwards. India offers variety of cases with high incidence of life style diseases, cancer cases, neuro cases and the best of the best healthcare systems (India has more number of AIIMS than ever), the detection, monitoring and follow up during clinical trials have become far more convenient and connected. With digital revolution touching all the major metros and mini-metros, patients can be monitored real time. India has 388 million 4G users in 2019 and that can be a blessing for all the drug companies which plan to monitor the trials real time and reduce/minimise adverse events. Compared to markets like Indonesia where commuting is an issue, or African countries where communication is a major problem or Western Europe where the cost of trials are expensive and patients have limited health issues, but language is major barrier; India offers infrastructure, easy policies (in 2019) and the government has propensity to facilitate more companies considering Indian market as a ground for clinical trial.
Considering the slow growth in the clinical trial sector in the last 10 years, this decision has come at a time of election year in the country when things might turn for betterment or worse.
What remains unaddressed is the monopoly of giants in the CRO market? Currently, it is driven by few big names such as IQVIA, Parexel, Clintec, PPD and smaller ones are struggling to keep pace. More and more mid and SME in the CRO segment should be incentivised to promote healthy competition and break down the monopoly. This will directly bring down the cost of conducting trials in India. I am sure the drug companies would look forward to such move by the next government post May 2019. Unless closely nurtured, this industry can lose its way and get entangled in the complexity of trials. Whether the golden period continues or is over-ruled by the next one, will define the growth path of clinical trials in India.