21 October 2003 | News
to be a major success in five years,"
DBT chief Manju Sharma
The July issue of BioSpectrum had highlighted the Top 10 hurdles hampering the growth of the biotech industry. The report had projected the views of leading industry leaders on this issue. The message has reached the country's top policy makers. India's topmost biotech policy maker, secretary, Department of Biotechnology (DBT) Dr Manju Sharma, provides point-by-point answers to the 10 issues and concerns raised by the BioSpectrum report.
List of Hurdles
These were some of the comments voiced by the industry.
Hurdle 1: Multiple regulators
"We need to set up transparent guidelines for making life easier for the industry. What is needed is a set of procedures that are accessible to everyone. Also, there should be targets and deadlines that should be applicable to the regulatory bodies to ensure speed of operations. The industry should be consulted when framing policies for the biotech industry. What the DBT can do is to set up a section on its web site to provide information useful to the industry, similar to the web site of the National Institutes of Health in the US."
Anuradha Acharya, CEO, Ocimum Biosolutions
Hurdle 2: Wavering over IPR
"The biotech sector is committed to the WTO TRIPS patent regime in 2005. However, mixed signals being given from the government and various other sections suggest that this may be delayed. If this is so, it will severely handicap the biotech sector in India where R&D services are unable to grow prolifically largely on account of our present IPR norms. There is also a vital need to introduce stringent patenting norms as many biotech firms are investing heavily in proprietary R&D which needs guaranteed protection."
Kiran Mazumdar Shaw, chairman, Biocon
Hurdle 3: Policy on GM products
"A national policy framework has to be cleared. Bt cotton took nearly seven years to get cleared. GM mustard is not cleared. This should be overcome and a clear-cut policy must be there. NGOs are making a misinformation campaign against the GM crops. We need to make the people aware. The real facts should be disclosed to the public. India can develop GM crops within the country. We are now importing it from foreign countries. If there is a specific regulatory framework, the companies in India will be having the courage to enter in to this field."
Deepak Mullick, MD, Advanta India
Hurdle 4: Inadequate government support
"More than 50 years of restrictive policies have not helped our industries. Why not try the alternative approach? Get rid of restrictive policing strategies. Start an era of mutual trust, which is a fully accountable."
BN Banerji, emeritus scientist CSIR at the UDCT, Mumbai University
Hurdle 5: Lack of seed funds
"The biotech industry is capital intensive. Initiatives need to be taken by the government to promote the biotech industry. To address the financial, legal and management intricacies of biotech, initiatives should be taken at the policy making level."
Villoo Morawala-Patell, CEO and founder, Avesthagen
Hurdle 6: Stiff norms for animal tests
"Animal toxicity data is compulsory for recombinant drug development. The government has to be forthright in this direction. This affects even the larger pharma sector."
Biocon and ABLE chief Kiran Mazumdar Shaw
Hurdle 7: Lack of appropriate biotech education
"We at the industry side have to give training to the students for a period of two years although they have done courses in biotechnology. The universities need to think on these lines while designing the syllabus for biotechnology courses." Shama Bhat, MD, Bhat Biotech
Hurdle 8: Irritants in clinical trials
Complex regulatory systems and cumbersome processes involved in getting regulatory approvals stand in the way of more clinical trial orders flowing into the country.
Hurdle 9: Infrastructure constraints
Biotech companies require some highly expensive equipment, each costing crores of rupees, to conduct certain basic tests. These are required for short duration and for specific purpose. Investment in such equipment is a drain on small companies as their use is limited.
Hurdle 10: Weak industry-institution linkages
"The national scientific institutes and the industries need to work together to ensure reliable and fast results. Publications don't make money. Patents do."
BN Ganguly Agharkar, chair professor and emeritus scientist, CSIR, UDCT, Mumbai
Note: Dr Manju Sharma's comments are not in response to the individual comments, but the issues (the hurdles) identified by BioSpectrum.
It may be noted that India is not the only country where different types of licensing systems exist; this is the scenario worldwide. However, it is perceived that the Indian regulatory mechanism is working coherently starting from industrial licensing from the Ministry of Commerce and Industry to regulatory clearances from the Administrative Ministries (AMs) concerned, apart from Ministry of Environment and Forest from the environmental angle. All the regulatory mechanisms involved in the promotion of biotech sector have been playing a proactive role. The issue of cumbersome approval protocol by the present regulatory process is being resolved on a sustained basis. The approval process for all biotech, especially the recombinant DNA (rDNA) products, follows the Environment Protection Act (EPA) for biosafety regulations. And as per the law, the biopharma-ceuticals cannot be made a corollary because the EPA is meant to regulate the Genetically Modified Organisms (GMOs) and the products thereof in entirety. Though the time taken is being reduced.
A "single window processing mechanism" has already been put on the DBT's website for the benefit of the industry as far as biosafety regulatory issues are concerned. Corporate sector support to various biotech sectors has always been appreciated.
The issue of "single window processing mechanism" for biotech products has been discussed in various forums at length. This mechanism is available for all mega projects involving FDI of Rs 100 crore or more under the Foreign Investment Implementation Authority (FIIA) with its Fast Track Committee (FTC) existing in DBT.
However, since the biotech products cut across all disciplines of science and fall into various categories of industry involving a number of AMs, it is not possible to have a single window clearance mechanism for all biotech products. It is well organized for rDNA products within the Ministry of Environment and Forests, Ministry of Health, Ministry of Agriculture and Department of Biotechnology. In fact, it would not be an exaggeration to say that the Indian biosafety regulations for rDNA products are one of the best in the developing countries.
As far as the product patent regime is concerned, DBT has seen that most of the biotech giants and nascent companies are confident of meeting the product patent requirements after 2005. The government is already in the process of preparing a road map for the steps to be taken prior to the framing of these legislations on product patent in association with various industry associations like FICCI, CII and ASSOCHAM. The Ministry of Commerce and Industry is actively engaged in the preparation of this road map. Since most of the biogenerics would be out of the patent regime, the Indian biotech industry would have an upper hand provided they spent more on indigenous R&D. The biopharma companies should not be ambiguous on the IPR issues and should get involved in capacity building and awareness generation within their corporate houses. The product patent regime would automatically give guaranteed protection to the investors in indigenous R&D under the new road map which would involve procedural improvements, making the Patent Act user friendly and simple, as envisaged.
on GM products
The framing of policy on Genetically Modified (GM) products involves a number of AMs and agencies like Ministry of Agriculture, Ministry of Health and Family Welfare, Ministry of Commerce and Industry, Ministry of Environment and Forest, Ministry of Science and Technology, Ministry of Food Processing, ICMR, ICAR, CSIR and various national institutes. GM products are still in the nascent stages for introduction in India and the country is slowly gaining experience from the data trickling from worldwide regulatory authorities for GM crops. It would be important here that industry takes the message that GM products are going to stay and are the products of the future. These have been well accepted in the healthcare sector and would pave the way for agriculture also, as there has been promotion of successful technologies abroad especially in the agri biotech sector. During the last two years DBT has taken ample steps in generating awareness on the biosafety issues by organizing various seminars throughout the country. Apart from this, the Department has conducted six seminars on the introduction of biotech products including GM products, in association with the Ministry of Small Scale Industries, Agro and Rural Industries for sensitization of small-scale sector in this area.
The contention that in developed countries, the government supports the
biotech sector with huge investments in research and setting up the
infrastructure is not correct. Indeed, in India more than 97 percentage of
the government support has been invested in creating infrastructure for
biotech research. The developed countries have a higher contribution from
the private sector in creating infrastructure and on the contrary, it is
less than 3 percent from the private sector in India. As regards the
comments that the bureaucratic procedures in financing the projects are a
hurdle for the biotech industry, it seems to be an individual's view.
DBT interacts with more than 2000â€“3000 scientists in the country every
year and more than 200 scientists are involved in the evaluation of
projects in which their own projects are also considered. The government
has always been promoting the academia, institution and industry
interaction, which has been lagging in the past. It is due to the capacity
building and awareness generation efforts of DBT that the industry has
started interacting with academia and national laboratories to develop
indigenous technologies, which would prove a golden stick in the coming
scenario of product-patent regime. The government has never come in the
way of the "free hand" demanded by the industry and has in fact,
helped them by providing various incentives from time to time. The Budget
2003-2004 has given many incentives to biotech industry, which has now
been brought at par with IT sector. The government has played a proactive
role in developing strong links between the national laboratories under
CSIR, various departments in universities and IITs and the
Marketing biotech products is the responsibility of the industry as the market is driven by various forces. On its part, the government always prefers an equal level playground for all the biotech industries regarding competitiveness and benefit to the common man. The industry needs to develop its own marketing skills.
DBT has been spending more than 60 percent of its funds for extramural research in various national laboratories and universities. The department has made ample efforts in association with the Ministry of Finance to bring down the custom duty and countervailing duty from 25 percent to 5 percent in the Budget 2003-2004. Further, in accordance with various CSIR rules and regulations, provisions have been made under the Income Tax Act to avail 100 percent income tax free expenditure for companies involved in R&D.
of seed funds
The government has already initiated the process of seed fund as rightly pointed out by BioSpectrum, through Technology Development Board (TDB) and Technology Information Forecasting and Assessment Council (TIFAC) despite resource crunch at the national level. The estimate of Rs 200 crore as seed funds as pointed out by BioSpectrum would be a still much lower conservative estimate keeping in view the progress of the biotech industry in the country. The modern biotech industry is highly capital intensive and an amount of Rs 200 crore may prove inadequate depending upon the number of entrepreneurs approaching the seed fund for support. But at the same time the investment from industry must rise. For the small entrepreneurs the TDB and TIFAC are the instruments, which have become very popular as on date.
norms for animal tests
Animal testing has been routine in the drug development since decades. With the advent of science in general and biopharma-ceuticals and biotechnology in particular, we have gained enormous knowledge on the effects of drugs at the molecular level. With this advent in knowledge the regulatory system has been also strengthened so that human beings get safe and the best products for use. The norms for animal tests as stated "stiff" may be the contention varying from industry to industry. Scientists are developing alternate methods for drug testing which can avoid the use of animals. DBT has always been striving to generate projects to develop alternate methods like using cell culture systems, which are as effective and reliable as animal testing. This area of animals as biomedical models is now being restructured.
of appropriate biotech education
Biotech education has been one of the primary mandates of the Department of Biotechnology for the development of skilled human base for biotech research and industry. It has started two MSc courses in general biotechnology, seven MSc courses in agriculture biotechnology, a post graduation course each in medical biotechnology, marine biotechnology and neuroscience. Four MTech courses in biochemical engineering, bioprocess technology and biotechnology apart from various diploma courses which have been initiated in various universities and IITs of the country. A majority of these students are preferred by the industry as the admissions are done on a centralized competitive examination conducted by JNU. As far as curricula are concerned they are kept at par with the international level but the strength of an individual varies depending upon his own grasp and interest in the latest progress taking place around the globe. Special industrial biotech courses have been supported.
in clinical trials
The R&D companies already enjoy a weighted reduction in income tax as announced in the Budget 2003-2004 with the efforts of the Department of Biotechnology. The issue of data exclusivity should be looked into with larger perspective as it gives an upper hand to multinationals and has far reaching effect on various biotech sectors, especially for the products and processes in the agribiotechnology sector.
As has been rightly pointed out that common facilities and infrastructure are required by the small entrepreneurs and DBT has been instrumental in creating such infrastructure within the country from the very start since 1986. The infrastructure facilities for downstream processing, animal house, microbial type culture collections, routine sequencing, oligonucleotide sequences, import and distribution of biochemicals etc. have been working since the last one and half decade and providing service to small and large entrepreneurs. The concerns on restrictions may be hypothetical as these services are open to all depending upon the availability. The marketing issue is an individual issue but the department has always made efforts that indigenous products and processes should be preferred by the government system. The centralized system for the availability of journals and databases has already been created by the bioinformatics division of the DBT through its DICs and sub-DICs as well as uplinking of various universities and academic institutions in the country.
Industry should take more initiatives to interact with academia which have been sensitized enough to take up projects sponsored by the industry. Though the government efforts in this direction are continuous but the proactive role of industry is also required so that the needed infrastructure is created within the country and various academia and research institutions can be optimally utilized by the small entrepreneurs for product and process development. Power supply and marketing are the specific issues faced by some and cannot be commented upon by the DBT.
The issues raised seek the onus that who is responsible for such weak linkages-the industry or the academia. As far as the government role is concerned, it has strived for such linkages and various mechanisms have been developed. The Department of Biotechnology has encouraged industry, academia and government associations and has jointly funded a number of projects in association with industry to the academic institutions. The government has played a key role in the development of biotech products and processes and this is the reason that as on date the Department of Biotechnology could transfer at least 56 technologies to the Indian industry. Examples include the three products already in the market which are the import substitutes and one of the HIV diagnostics kit developed in association with industry has already taken over 90 percent of the market. One of the products for the treatment of kala-azar and systemic mycosis is less toxic and much cheaper than the imported product. The movement of scientists and researchers from academia to industry and vice versa has now started and it is hoped would pick up further.
The setting up of Biotech Consortium India Ltd (BCIL) was a major step in this direction. It has acted as a platform for academiaâ€“industry interaction and for technology transfer, preparation of feasibility reports, market survey etc. Similarly National Research Development Corporation (NRDC) also has stepped up its activities in biotech area. DBT has a proper arrangement with BCIL and NRDC for helping the scientists to transfer technologies.