After a decade of pain, there are some reassuring signs that the pharmaceutical industry may just be seeing the faint glimmers of light at the end of the R&D pipeline. A recent report from Thompson Reuters shows that 2014 had 46 new molecular entity releases, the highest in a decade. While the higher than usual number could be due to a windfall of delayed releases and approvals, what’s really worth noticing is that the quality of releases has changed for the better. For instance, according to the 2015 CMR Pharmaceutical R&D Factbook, one third of 2014 launches were for rare indications, mainly in the oncology arena, with many of these receiving orphan drug status. Phase III launches grew steadily while early development pipelines thinned out, with the industry embracing a ‘fail fast, fail cheaply’ strategy. Sparse early pipelines could also mean that these companies will need to find replacements once these drugs hit the market.
Most of these strategies are visible in AstraZeneca, the subject of our cover story in this issue. (See story, Getting the science right, pages 16-20). Every decade needs new strategies and it will be interesting to see how this business model plays out.
On the domestic front, EU’s ban of 700 formulations tested by GVK Biosciences has escalated into a trade dispute, with India’s Commerce Ministry calling off trade negotiations due in late August. In what is turning into a ‘who will blink first’ contest, one wonders at the long term implications of this stand off. India’s proposed national IPR policy dues to be released in a few months will see another such tug of war.
India’s regulators and regulatory infrastructure desperately need an overhaul if they are to cope with an industry growing at a fast clip. In this issue, we focus on the status of central and regional drug testing laboratories, with a Good Laboratory Practices’ special story on how some states and regulators are pushing for change and upgrading their facilities. NABL and WHO pre-qualification certification will go a long way towards instilling confidence in this framework. Our fervent hope is that other states follow suit sooner than later. (See story, A nudge in the right direction, pages 21-23).
Such a change is already underway at India’s IP offices, according to Nirmala Sitharaman, Minister of State for Commerce and Industry, who at a recent FICCI meet pointed out that the draft IP policy, focuses on stronger enforcement of IPR by increasing the manpower strength in IP offices and reducing the pendency of IPR filings. Most of the IP offices have gone online and it is hoped that doing away with the manual interface for applications, queries and decisions will speed up decision making.
The July FICCI meet was held to felicitate Micromax on acquiring the 1.25th million international trademark under the Madrid System, and the minister took the opportunity to emphasise that the final draft of the proposed national IP policy was arrived at after a transparent consultative process before being sent to the Union Cabinet for approval. This contention was disputed by academia but all stakeholders are awaiting the final release to see if the government has stuck to its stand to protect India’s interests. Going online was a no brainer, a long delayed decision. It is important to realise why the government was able to push this through. The Prime Minister himself has advocated that intellectual property is a means to create jobs and achieve the growth rates he promised the nation when he took office.
His message is reiterated by his ministers down the line, For instance, speaking at the same FICCI meet, Amitabh Kant, Secretary, Department of Industrial Policy and Promotion (DIPP), Ministry of Commerce and Industry, admitted that the key challenge before the country was to attain growth rates of 9-10 per cent year after year for 30 years. “We need to be a nation of job creators where innovation and creativity will be the key driving forces,” he said, underlining the role of India’s IP offices and the proposed IP policy in “building Indian brands that can effectively penetrate the global markets.”
The message is very clear: the promise of all round economic growth is the biggest nudge for change. Corporates are answerable to stakeholders and the stock market and therefore are forced to change much faster. Unless regulators feel the same push from the electorate, they will never feel the same urgency to buck up and stay relevant.