The unprecedented changes taking shape in the regulatory system is set to transform the Indian pharma market even as the industry rallies its way to the top league of world's pharma leaders.
The proposed reforms are expected to provide greater impetus to the smooth sailing of the US $ 8 billion India pharma market which, growing at a double-digit pace, is predicted to double its size to figure among the top five leading markets by 2015.
In an effort to ensure greater transparency and accountability in the regulatory machine which has been long slammed for inordinate bureaucratic delays, red tapism and ad hocism, India's drug regulator has embarked on an array of reforms, of late.
Signalling a thorough overhaul of the entire system, the very office of the Central Drugs Standard Control Organisation (CDSCO)-the policy making authority -has gone through a makeover clearly in line with corporate offices. Dr Surinder Singh, who took charge as the Drug Controller General of India (DCGI ) in February 2008, has added further momentum to the reformatory process.
Setting clear time frames for giving drug licenses and clinical trial approvals and the display of the status of the applications at the lobby itself is considered as measure to assure transparency in licensing and approval processes.
Now companies can get an export or test licence cleared in four weeks or registration of a fixed dose combination (FDC) can be availed in 12 weeks' time. "There's no need to loiter around to know the status of their applications. It is displayed on the notice board everyday," said Dr Surinder Singh.
Also, if the clearance gets delayed beyond the prescribed time limit, there is a special section under assistant drug controllers for complaints. Different weekdays are dedicated for redressal of different sections like biotechnology, medical devices etc, explained the drug controller.
"The reforms initiated by the current DCGI definitely provide much needed impetus to the industry. Some of the key activities initiated by him are already showing positive results such as speedier response time and enhanced transparency. We believe that the DCGI is pro-work and pro-results which is synonymous with pro-industry," commented Dr Naveen A Rao, managing director, MSD Pharmaceuticals Private Limited India-the local arm of the US drug giant. Dr Rao, however, emphasised that the reforms needed to keep the momentum going in order to stay sustainable and relevant.
Though the changes are welcomed, in general, the industry still feels that the much-awaited reforms require to be far more expedited. ``These are long overdue reforms and need to go even faster,'' pointed out Dr (Mrs) Swati A Piramal, director, Piramal Healthcare Limited.
"For example it takes 8 months or more to constitute a phase I approval committee. In addition the time will be taken for them to meet and decide a go ahead on a proposal for a clinical trial. In other countries the total time for approval is just 28 days. UK, Canada, European Union and the USA. This means we have a huge regulatory bottleneck on Indian innovation. As the patent clock is ticking this delay is unacceptable. Good legislation is good for industry," added Dr Piramal.
Plans are afoot for Rs 250 crore e-governance programme in CDSCO. The initiative, which is being done in association with the New York-based technology solutions provider MGRM, will enable the companies to file, track and review applications online from anywhere in the world, once fully implemented.
As part of the programme to make the CDSCO an one stop office, experts from world's leading drug regulators like US FDA and Health Canada are roped in train and update their Indian counterparts in disciplines like clinical technology and pharmacovigilance. These agencies, along with WHO, is currently assisting CDSCO streamline its functioning as well as improving infrastructure facilities.
Crusade against counterfeits
The drug regulator has come up with some bold steps to weed out the substandard and unscientific drugs and combinations. Counterfeits and spurious medications are reportedly flooding the Indian market in considerably higher levels. This also gives rise to assumptions that India could be the source of spurious drugs spreading world over, denting India's prospects repute as a quality supplier of low-cost generics across the globe.
Apart from organising a countrywide survey to assess the real magnitude of the spurious drug menace, the regulatory authority has mooted tougher penalties like life imprisonment and non-bailable arrest for manufacturing and selling spurious drugs.
Regarding the 294-odd controversial FDCs currently in market, a specific action plan is learnt to have drawn up after evaluating their safety profiles. Mandatory submission of clinical data for FDCs, the centralisation of drug licences through CDSCO's zonal offices, centralisation of manufacturing licences are among the proposed policy initiatives towards this direction.
FDCs are an important drug class and therefore clear guidelines on the development and approval of their therapeutic equivalents is necessary. Currently only Appendix VI exists which has a few paras on the approval of FDCs and does not stipulate the developmental needs in detail, averred Ranjit Shahani, vice-chairman and managing director, Novartis India.
``Global pharma is looking to India to develop such incremental innovations in the form of FDCs with sound medical rationale and therapeutic need. Thus the need for India's leadership considering the fact that we are the only country with such an extensive use of FDCs for decades and are therefore in the best position to develop 'dos & dont's of FDCs' for the rest of the world,'' Shahani said.
Efforts are also underway to develop separate norms for medical devices -which are currently covered under drug laws as therapeutics-and stringent practice guidelines for the country's fledgling clinical trial business.
Phase 1 for foreign molecules
India's CRO industry has grown many-fold over the past years, raising the prospects that the country could well become a hub of clinical trials soon. Vast reserve of genetically diverse and drug naïve patient population in cancer, cardiovascular, diabetes therapeutic categories; speedier enrolment of patients; a large number of hospitals and specialists, lower costs are the major attractions overseas drug makers look at in India for outsourcing.
Realising the potential, Dr Singh has recently announced that he would further streamline addressing the lacunae in the Schedule Y - the section in Drugs & Cosmetics Act dealing with clinical research - including the removal of phase lag for first-in-man studies for overseas drug firms.
Presently, Indian laws do not permit phase I human trials for molecules developed outside the country unless they are tested safe elsewhere. ``The next step is to allow first-in-man studies for foreign molecules as they have an advantage of being already scrutinized by the regulatory authorities from the source country before their filing in India. The removal of this dichotomy in the regulations for phase I will make our regulations on par with global norms and accelerate the globalization of clinical trials,'' opined Shahani.
While the reforms gain momentum, winning plaudits from global firms, it remains a fact that all the new proposals do not go down well among all quarters in India's diverse pharma sector. The desi industry, especially, the small scale industries sector questions the wisdom of harsher punishment for substandard drug makers while leaving the term ``substandard'' still open for definition. Likewise they also fear that strict enforcement of cGMP standards, elimination of FDCs etc are arbitrary and could adversely affect their interests.
"It is desirable that all stakeholders are consulted in setting up criteria and in deciding the subsequent action plans to implement the changes," said D G Shah, director general, Indian Pharmaceutical Alliance -a conglomerate of leading domestic firms. IPA, however, is supportive of all measures aimed at strengthening the regulatory infrastructure of India. "In fact some of these measures may hit many units adversely, but they are in the long run beneficial for the country," he added.