Like many other industry sectors The Pharmaceutical Sector is keeping its chin high in search of possible restructuring that can smoother many processes within various frameworks. With an aspiration to be an ethical business pie of the India Inc. here’s a wish list by Sanjay Buch.
Need to speed up the process of approvals for launch of new products and for permissions to undertake bioequivalence studies.
Need to simplify procedures linked to the Foreign Investment Promotion Board with respect to the pharmaceutical industry. This will ensure fund raising becomes easier for pharmaceutical companies and will also ensure foreign investments can easily come into the country
Need for the Government to create or encourage the setting up of industrial parks and special economic zones for the pharmaceutical industry. Given that pharmaceutical is a specialized industry where many companies have similar requirements for basic infrastructure, it is important to create industrial parks or SEZs that are customized to cater to the needs of this industry.
The Department of Pharmaceuticals has reportedly started comparing Indian drugprices with their international equivalents in terms of the ‘purchasing power parity’ and ‘per capita income’ and not just their prevailing prices in various developed markets converted into rupees. With such comparisons the government has already started voicing that prices of medicines in India are not the cheapest but on the contrary one of the costliest in the world.
Thus, one of the critical challenges of the Indian Pharmaceutical Industry continues to be delivering affordable medicines for alarge section of the population of the country, as expected by the government. Reported high profitability, at least, of the listed pharmaceuticals companies gives an impression to the stakeholders, including the government, that there is a scope for further reduction of pharmaceutical prices in India.
Pharmaceuticals being covered under the ‘Essential Commodities Act’, empower the government to announce the ‘administered price’ for essential medicines. Current debate and deliberations on the New Drug Policy both by the Supreme Court and the Group of Ministers is a case in point.
From the perspective of the global innovator companies across the world, ‘lack of a robust innovation friendly ecosystem’ in India is still a major challenge. However, home grown companies feel otherwise. This is mainly because, before enactment of the Indian Patents Act (amended) 2005, it was widely reported that mainly for the interest of Public Health and probably also to ensure that the growth of the domestic pharmaceutical industry does not get very adversely impacted, the Parliament of India ensured inclusion of a number of ‘safeguards’ including checks on ‘evergreening’ of pharmaceutical patents and broader provisions for the grant of ‘Compulsory License’ in the statute.
Such provisions in the Indian Patents Act throw a major challenge to the global innovator companies spreading across the continents to get many of their new molecules patented in India and subsequently launch in the country.
India still needs to generate enough credible data to convince itself and then to establish that counterfeit drugs are posing a growing menace to the humanity. All stakeholders should join hands to address this public health issue, leaving aside petty commercial interests, be it generic pharmaceutical companies of India or research based pharmaceutical players across the world. The other side of the coin is that counterfeit versions of high value and/or high volume brands of the pharmaceutical companies in India are adversely affecting their business performance posing another major challenge.
In the increasingly globalized economy, strict conformance to high regulatory standards like, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) pose another major challenge for the pharmaceutical industry in India.
Those pharmaceutical companies who are involved in manufacturing and export of drugs and pharmaceuticals are required to meet standards set up not only by the Drug Controller General of India (DCGI) and/or the State Drug controllers, but also of the regulatory authorities of the respective countries, where their products will be exported.
We have been witnessing for quite some time that ethical concerns related to the pharmaceutical industry, spanning across clinical trials to ethical marketing practices, are hugely bothering a large section of the stakeholders, solely for the interest of the patients.
Such concerns are assuming greater proportion, as the pharmaceutical industry is increasingly facing stringent regulatory and media scrutiny in gradually expanding areas of business operations. Thus, to overcome this challenge, there is a dire need for the industry to move beyond its usual bottom-line centric model to a transparent, comprehensive and implementable ‘Ethics and Compliance models’, which are well meshed with all other business processes.
Following are the key pharmaceutical industry related issues, with an integrated approach, to strike a right balance between the growth fundamentals of the industry and the Public Health Interest:
One point of concern is the regulatory framework. Under Indian law, all drugs which qualify as ‘bulk drugs’ must have an end-price that is regulated by the government – the recent DPCO 2013 (Drug Price Control Order) seems to have increased the number of bulk drugs from 74 to 348. This may prove to be a deterrent to Indian pharma corporations leading to a lot of exits.
Recently Ranbaxy had to pay $500 million fine as a result of its non-compliance of generic drugs. This is what essentially has sparked off the USFDA (United States’ Food & Drug Administration) to go in for more surprise checks and even open up an additional office at Hyderabad (to check if Indian pharma companies which export to the US are compliant with US law and manufacturing standards). Though allegations have been made towards it for taking on Indian pharmaceutical companies more harshly than those of its other global counterparts, it cannot be denied that India is one of the topmost places for generic drug production. It accounts for about 40% of the generic products in the US market.
Move to establish an integrated regulatory system through the constitution of a National Drug Authority so that quality regulation and price control is performed by the same agency Establishment of pharma covigilance centers at national, zonal and regional levels to monitor adverse drug reactions.
Move to bring nearly 374 bulk drugs under price control and regulate trade margins Capability strengthening to monitor clinical trials, including the setting up of the Clinical Trials Registry of India.
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