In the letter, the IPA made a few scathing remarks noting that the decisions had the industry “perplexed by the propriety, not just legality” and were indicative of a trust deficit between the industry and the regulatory machinery.
Taking a critical view of the local drug regulatory machinery, the Feb. 27 IPA letter signed by DG Shah, secretary general of the Indian Pharmaceutical Alliance, said while the policy framework was correct, problems cropped up in the Indian industry due to “imaginative and arbitrary” implementation of the pricing policy. It alleged that an “unbridled turf war” between the department of pharmaceuticals and NPPA resulted in unwarranted price fixation and open defiance of the government’s corrective orders.
The group also suggested a host of measures to promote the sector pointing to the challenges to exports of generics to the US such as uncertainties from the Trump Administration and the pressure to change India’s intellectual property laws.
In addition, the IPA, which includes Sun Pharma, Lupin, Cipla, Cadila Healthcare, Glenmark and Dr. Reddy’s as its key members, took issue with moves of local regulators that last year imposed a ban on hundreds of fixed dose combinations and price fixations by the NPPA.
Among the key issues, it highlighted that early signs from the Trump Administration do not augur well for the Indian pharmaceutical industry. Although India can fill in the void created by the abolition of Obamacare, it categorically stated that the gains will not come easily and the future remains unpredictable.
“The Trump Administration may get tough on the patents and other intellectual property rights. It may invoke the provisions of the Trade Facilitation and Trade Enforcement Act of 2015 to curtail imports of medicines from India,” the letter said, adding the US government may also adopt border tax adjustment, impose a reformed corporate tax in a bid for “levelling the playing field without starting trade wars.” The IPA cautioned the government and said irrespective of which way the Trump Administration moves, it is certain that exports of generics from India would be hit.
As a set of initiatives to boost the industry, the IPA suggested a plan to build capacity and work closely with the US department of commerce, the Indian Mission in Washington and key officials at the US FDA.
The group also sought a preferential treatment for clearance of the backlog of the ANDAs filed by Indian drug companies. The IPA called for a quicker response to the Establishment Inspection Report (EIRs) issued by the US FDA as long delays hold up re-inspections and clearances of the manufacturing sites, leading up to further delays in resumption of supplies by approximately two to three years.
Apart from the specific measures for the US market, the IPA suggested to the NITI Aayog that the government should make use of the WTO Trade Policy Review to contain USTR pressure on the IPR regime. It also advised on leveraging the UN High Level Panel Report on Access to Medicines to stay with TRIPs compliant IPR Regime.
The IPA’s note dwelt on the efforts of Indian companies in Japan but admitted that it has not met with much success. “They have tried engaging local consultants, partnering with local companies and outright acquisitions. But have found non-tariff barriers as the main hurdles,” the IPA letter further said.
The industry has called for the government intervention to facilitate and set up a framework to satisfy mutual needs, of which one action could be to encourage the Pharmaceuticals and Medical Devices Agency (PMDA) to set up its office in India. It added exploring a re-look at Europe while exploring an entry into Japan and China.