PRDC Report

VI PRIORITISATION OF R&D

9. Disease pattern

The WHO Report of 1997 has estimated that 43% of deaths in developing countries were caused due to infectious and parasitic diseases, 24.5% were due to circulatory diseases and around 9% each due to cancer and neonatal diseases. The Global Burden of Disease 1990-2020, Harvard, WHO, World Bank study indicates that the next two decades will witness dramatic changes in the health needs of developing regions, with depression and heart disease replacing traditional killers such as infectious diseases. However, tuberculosis is expected to continue as a major cause of death with the HIV acquiring serious proportions. Table 3 gives the comparative mortality caused due to diseases in the developed and developing world.

Table 3. DISEASE MORTALITY IN THE DEVELOPED
AND DEVELOPING WORLD

Causes of mortality	Mortality in % & (thousand nos.)
	Developing world		Developed world
Infectious and parasitic diseases	43.0	(17,161)	1.2	(151)
Circulatory diseases	24.5	(9,778)	45.6	(5,522)
Cancers	9.5	(3,802)	21.0	(2,544)
Respiratory diseases	4.8	(1,909)	8.1	(979)
Prenatal and neonatal diseases	9.1	(3,626)	1.0	(119)
Maternal causes	1.5	(582)	0	(3)
Others and unknown causes	7.6	(3,063)	23.1	(2,798)

Source : World Health Report 1997 (WHO)

New drug introductions for diseases of significance and relevance to developing countries have been less than 1% of the total new drug introduction world wide. This re-emphasises the need for such drug development and the potential opportunity for Indian pharma R&D.

It is essential for the Indian R&D to initiate new drug development for diseases of relevance to Indian population not only presently but in the years to come as well. Based on this assessment the priority R&D were identified as follows:

Communicable and infectious diseases : T.B., Malaria, gastro intestinal infections, (e.g. cholera, hepatitis, etc.), kalaazar, filaria, H.I.V and sexually transmitted diseases (STD’s), lower respiratory diseases.
Cardiovascular diseases : Hypertension, atherosclerosis and myocardial infarction, coronary artery diseases, rheumatic fever and heart disease.
Cancer
Eye and ear diseases
Metabolic diseases : diabetes, arthritis, dyslipidaemia and obesity
Neurological diseases : e.g. Alzheimer diseases, Parkinsonism, Epilepsy.
Nutritionally linked diseases: Malnutrition,Anaemia,avitaminoses.
Paediatric diseases : Neo-natal diseases to reduce infant mortality.
Reproductive diseases
Respiratory diseases : Asthma and other allergic respiratory disorders.

The rate of change is not going to slow down anytime soon. If anything competition in most industries will probably speed up even more in the next few decades.

Professor John Kotter,
Harvard Business School
From "Leading Change"

VII NEW DRUG DEVELOPMENT

10. The discovery process

New drug development is knowledge intensive, time consuming and risky. The development process could broadly be divided in two major stages viz. preclinical and clinical. The objective of preclinical studies is to come up with a molecule that is effective against the disease vector and safe in animal testing. This is the Investigational New Drug (IND) stage. This stage of investigation may take anywhere between 3 to 5 years and cost between $100-150 million overseas or about Rs.40-60 crore in India. This implies that IND can be undertaken at less than one-tenth of the cost in comparison to the cost in other countries.

Preclinical investigations need an assembly of multi-disciplinary activities covering design and synthesis of new chemical compounds, bio-activity screening for both in-vitro and in-vivo testing, toxicity, pharmacokinetics, metabolism, bioavailability studies and scientific expertise in areas such as organic and medicinal chemistry, crystallography, molecular modelling, bio-chemistry, microbiology, pharmacology, toxicology etc. (Fig.1 – page 17). On satisfactory completion of the preclinical studies the dossier on the IND is submitted to the regulatory authorities (the Drug Controller General of India) for permission to study its use in human clinical trials, in phases of I, II, and III with review at each phase, (Fig.2 – page 18) to ensure efficacy and safety.

If an IND passes through all these clinical studies the compound becomes a drug that could be marketed. The clinical studies take generally 5 to 8 years and it is estimated to cost approximately $300 – 350 million abroad and around Rs.100 crore in India. Clinical trials need GCP conforming facilities and expertise of clinicians, clinical pharmacologists & toxicologists & analytical chemists.

At present, out of ten thousand chemical compounds screened, the chances are that only one of these may become an approved drug. Efforts are being made and strategies are being drawn to improve the success rate by intelligent synthesis using conventional and modern combinatorial techniques and then screening these sources of chemical compounds. Also plants, microbes, fungi, insects and various venoms are an excellent source of chemical diversity and thus new and novel chemical compounds isolated from these extracts could also be screened.

Another promising source is the drugs, which are being used routinely by clinicians for treating specific diseases but which are known to have strong side effects. They may also be difficult to synthesise, separate and purify. The therapeutic value of some of these drugs can be enhanced by using the basic components of the structure as a base, which gives the biological activity, and modify or substitute those associated structures, which are responsible for the side effects, or may be difficult from chemistry and engineering point of view. Also some times vigilant clinicians notice new therapeutic applications of the routinely used molecules introduced for treating a specific disease. Such information can also be a valuable source, provided it is collated, analysed and disseminated systematically. Similarly some drugs with high toxicity can be a good source for new drugs. By modifying and directing their delivery to the desired sites in biophases, the dosage and toxicity can be reduced.

Indigenous medicinal systems use some herbs, which increase the bio-availability while reducing toxicity. This traditional wisdom can be advantageously deployed to discover molecules based on adjuvant, bio-enhancers and detoxifiers, especially for those diseases, where long term treatment is necessary like in the case of cancer, diabetes, hypertension, tuberculosis and HIV, etc.

India has an excellent expertise in developing new and innovative processes for known molecules. This capability needs to be exploited in a greater measure as these are large number of molecules developed in the west as new chemical entities, which are also ready for clinical trials. The existing expertise in the country can also be used for developing new and innovative processes for these molecules, which have a therapeutic potential.

12. Facilities needed

Animal testing is essential for effective in-vivo screening of disease conditions so that meaningful experimental data could be obtained, which will enable human trials to be undertaken. This larger good to mankind needs to be balanced vis-�-vis animal rights in devising a balanced legislation and guidelines for animal testing & import. At the same time the scientific community engaged in biomedical and drug research as responsible members of society have a moral obligation to evolve a self regulatory system, which will minimise the use of animals, decrease the pain and distress caused to the animals under test. The committee recommends that basic changes are needed in the legislation allowing (i) import of animals, (ii) contract research, (iii) Provide legal status to institutional animal ethics committee.
Clinical trials are a scientific and regulatory necessity for the evaluation of new drugs and other products, devices in human subjects. These are carried world-wide before new products are introduced. Clinical trials provide efficacy and safety of a new treatment in patients. However, there are very few centres, where valid and high quality clinical trials can be undertaken in India at present . A unique opportunity for India to become a leading centre to conduct clinical trials is therefore not being availed fully. There is an urgent need for establishing new centres of clinical pharmacology, which can undertake either disease or drug based clinical trials. Creating additional centres and strengthening existing centres will facilitate conducting clinical trials of new products.

There is inadequate international commitment to and investment in drug discovery for infectious and parasitic diseases, which are endogenous to the developing countries. Many of the disease pathogens are virulent & hazardous and proper containment facilities are needed for their handling and conducting R&D. India has no option but to create these facilities in order to develop drugs to ameliorate the suffering of the people.

Thus in order that Indian pharma R&D earnestly takes up new drug discovery in its diverse facets, it would need to have adequate facilities in following areas:

(i)             Combinatorial synthesis;
(ii)            Cell lines and new molecular targets for various diseases;
(iii)           In-vitro testing facilities;
(iv)           Structure based molecular modelling;
(v)            Animal house facilities conforming to Good Laboratory Practice (GLP);
(vi)           Disease specific transgenic animals;
(vii)          Containment facilities at appropriate levels;
(viii)         Clinical trial centres conforming to Good Clinical Practice (GCP).

The mechanism for using these facilities jointly by R&D pharma industry, academic and research institutions is given in Fig.3

Fig: 3 MECHANISM FOR USING THE FACILITIES JOINTLY

Besides the creation and use of these facilities jointly, India would need to expeditiously formulate, an appropriate and comprehensive policy and legislation for implementation of GLP and GCP monitoring authorities for non-clinical safety data and chemical testing results, which would need to be internationally accepted. Further for optimal and meaningful utilisation of these facilities import of necessary number of animals and contract research needs to be permitted. The capital requirement for these new facilities is provided in (Table 4 – page 23).

Table 4. CAPITAL REQUIREMENT FOR NEW FACILITIES

The type of facility	Number needed	Estimated Capital Investment	Expertise required	Existing place of known expertise
Combinatorial synthesis	8	Rs. 1.25 crore/facility	Organic Chemists trained in comb. Chem. At least 2 chemists/facility	CDRI, IICT, NCL, RRL-JM, RRL-JT, RRL-TVM. Ranbaxy, Reddy’s Labs, Torrent, Cadila health care, NPIL and Wockhart
LC-MS facilities	8	Rs. 2.5 crore/facility	Training persons in mass spectrometry	CDRI, IICT, RRL-JM, & JT. Dabur, Himalaya drug, Zandhu, Charak & NIPER
Standard Reference Material	2	Rs. 2 crore/facility	Analytical Chemistry	CDRI & Nicholas Piramal
High throughput screening	4	Rs. 3.5 crore/facility	Computer Programmer, Electronic Engineer, Biochemist or Molecular Pharmacologist trained in the subject, at least 1 scientist/discipline/facility	Ranbaxy, Reddy’s Lab. CDRI, NIPER, IICT/CCMB,
Bio-informatics	3	Rs. 2 crore/facility	Theoretical Physics, Molecular Biology, Information Science	CCMB, IMT, CBT
Genomics and Proteomics	2	Rs. 15 crore each facility	Trained in Mol. Genetics/Protein Science at least 4-5 Scientists of each discipline.	CBT, IMT, CCMB, CDRI, IISc, TIFR, JNU, SCDU, AIIMS, NII and NCCS
DNA/rapid sequencing	1	Rs. 3 crore	Molecular Biologists (5 in no.) & Protein Chemists	CCMB, CDRI, IMT
Structure based drug design & NII, Molecular modelling	2	Rs. 10 crore/facility	Scientists having background of molecular modelling, molecular biology, protein chemistry and structural Biology, at least 2 Scientists per discipline/facility	CDRI, IMT, IICT, IICB,
BSL4 Containment facility	2	Rs. 20 crore/facility	Scientists trained in microbiology, Tissue Culture and Animal Sciences 5 Scientists/discipline/facility	NARI, CDRI, IMT, NII, AIIMS, SCDU, IISc, TRC, NCCS, CJIL, CBT
Transgenic facility	1	Rs. 10 crore	Experts in animal breeding and animal health monitoring plus trained manpower in constructing new transgenics 10 Scientists + 10 other staff	CDRI, CCMB, NII
Pharmacokinetics and metabolism	1	Rs. 5 crore	5 Scientists + 5 other staff	CDRI, NIPER, Ranbaxy, Dabur, NIPER Reddy’s Lab., KEM
Regulatory toxicology	1	Rs. 6 crore	Toxicologists, Pathologists and Haematologists	NIN, CDRI, ITRC
Clinical pharmacology	5	Rs. 6 crore/facility	Training clinicians 4-5/facility	KEM, PGI, NIN, TRC

13. Human Resources

While India has adequate human resource in conventional methods of drug discovery, the newer tools of drug discovery have yet to be mastered. This may need both re-furbishing the skills and knowledge base of some of the existing manpower as also acquiring these skills ab initio. It has been estimated that a viable drug discovery programme, as envisioned in the vision by 2005, would need about 900 highly skilled and trained manpower as indicated in Table 5.

Table 5. HUMAN RESOURCE NEEDS

Expertise	Number of *P.G’s and above
Medicinal chemistry	200
Combinatorial chemistry	40
Bioinformatics and structure based molecular modelling	30
Genomics and proteomics	200
New targets discovery and validation	100
High throughput screening	50
Clinical pharmacology	50
Regulatory toxicology	75
Animal testing /development	50
IPR management (with technolegal expertise)	50

*P.G’s : Post graduate qualified persons

It needs to be emphasised that it is the universities, which are the fountain heads of knowledge and also the creators of human resource, that should meet the demands of the industry. Unfortunately, the declining standards of the university system in India are reaching alarmingly low levels, not only due to the lack of adequate budgetary support, but also due to extreme bureaucratic controls and delays. To improve the situation, revitalisation of our university systems needs to be given the highest priority. Furthermore, new human resource generation in frontier areas of science (such as bioinformatics, genomics, proteomics etc.) cannot just be left only to the university systems but accelerated in a networked manner with the other knowledge and innovation centres (such as CSIR laboratories). The university and the non-university system together must assume the responsibility of creating such a highly skilled and specialised manpower. Thus a facilitation of the partnership of such centres with universities as well as providing a deemed university status to some of the centres of excellence could augment the Indian capacity to create such manpower.

VIII INDIGENOUS SYSTEM OF MEDICINES

14. Status

The wisdom and experience of India’s indigenous health-care framework is ensconced in Ayurveda, Siddha and Unani systems. Even today these systems continue to cater to the health-care needs of sizeable sections of the population, the knowledge of which is in public domain. The therapeutic agents used in these systems are based on indigenous biodiversity, unlike modern therapeutics which are based on experimental validation. In other words, indigenous, health-care therapeutics are based on `experiencing’ rather than `scientific experimenting’. Thus it has been argued that the in-vitro and in-vivo animal validation may not be appropriate for proving their efficacy and safety but rigorous, scientifically conducted and documented clinical testing in recognised centres coupled with HPLC profiling of these products to define their chemical constituents would be more appropriate.

15. Needs

Considering the domestic and export potential for therapeutics based on indigenous systems of health-care, it is necessary to develop a product of uniform quality and standards using modern biological tools and to authenticate their efficacy and safety besides providing a HPLC profile range.

In order that Indian System of Medicine (ISM) succeeds in the west, the products of ISM should have an edge over their competitors in three areas viz. (i) core strength of the product, (ii) improved packaging and (iii) innovative method of marketing. Knowledge about international products too can also lead to entirely new optimised preparations, in which the best of each country is incorporated for a specific purpose. Thus active fractions from each, containing only a few molecules, if mixed with fractions from other systems, can yield a product, which has a much more potential and more efficacious than any of the products belonging to a specific system only. An R&D effort needs to be taken up in this area. A 'knowledge based' product has an inherent advantage over those products, which have only traditional and empirical observations as its knowledge content. The knowledge needs to be integrated into the traditional products by use of modern biology and chemistry.

There is a considerable scope of investigating fractions of product extracts used in indigenous therapeutics for devising optimised products, which can also qualify for IPR. If there is a fraction for the same disease and a number of fractions belonging to different plant extracts are effective, then these fractions can be combined to form a mixture. By fractionating this mixture further and by evaluation of the narrow cut fractions from it and remixing only the active ones, one can obtain yet another optimised product, which will be much more effective. Also those fractions which are active and contain limited number of molecules, can be isolated and characterised in order to develop new preparations which are molecularly definable. Much of the knowledge of our traditional system is in the public domain and can not be patented unless a human intervention step indicating certain inventiveness is brought in. Thus it is desirable that proper scientific documentation of our bio-resources and traditional knowledge base is prepared in the internationally accepted formats and media to safeguard from the possibility of grant of inappropriate patents to individuals and organisations in other countries. Major strengthening and modernising of the existing infrastructure is required to receive the full benefit from the rich source of knowledge. The possible capital requirement for establishing and strengthening of indigenous system of medicine are summarised in the Table 6.

Table 6. CAPITAL REQUIREMENT FOR ESTABLISHING AND STRENGTHENING OF ISM
FACILITIES

Facility	Recommend-ations	Numbers	Capital investment / faclity
Pharmaceutical laboratory of Indian medicine and homeopathic pharmacopoeial laboratory	Strengthen	2	Rs. 15 crore
Regional pharmacopoeial and official certification laboratories	Establish in relevant regions	6	Rs.3 crore
State drug testing laboratories	Establish in relevant states	14	Rs.4 crore
Safety evaluation centres for ISM Drugs	Strengthen centres with known expertise	5	Rs.3 crore
Clinical evaluation centres for ISM drugs	Establish and Strengthen centres with known expertise	6	Rs.4 crore
Research on drug related fundamental concepts of ISM	Strengthen centres with known expertise	5	Rs.3 crore
		Total Cost	Rs. 158 crore

The committee recommends a national policy to bring herbal and OTC medicines under one umbrella to maintain standards of safety and efficacy and move for harmonisation and standardisation with scientific data. A task force should be set up to:

(i)     formulate a new policy on herbal/OTC drugs
(ii)    establish a new cell for producing monographs of international standards
       on plant based products
(iii)   evolve strategies to respond to rapid changes in the science of herbals e.g. the
       advent of nutraceuticals/genetically engineered foods.
(iv)   form a national database on herbal medicinal plants
(v)    spur exports of value added herbal formulations.

                                You herbs,born at the birth of time
                                More ancient than the Gods themselves
                                O plants, with this hymn I sing to you
                                Our mothers and our Gods

                                The holy fig tree is your home
                                A thousand are your growths
                                You, who have a thousand powers
                                Free this my patient from disease

Hymn in Praise of Herbs in the Rig Veda
(circa 2500 B.C).

IX IPR RELATED ISSUES

16. The issues

Adapted from Time magazine

The pharmaceutical industry is intensely knowledge driven. Its intellectual assets are the key determinants to its competitiveness. A higher level of innovation and IPR management, coupled
with strategic manufacturing and aggressive marketing will determine Indian Pharma Industry’s future. The expectation can only be realised, when the rights of the innovators are not only protected but are seen to be protected through legislation and its effective enforcement. Thus strengthening the overall Indian IPR system, and not just merely amending the IPR laws is needed in which various stakeholders such as government, legislators, judiciary and industry have to play crucial role.

Government would need to :

Modernise the patent offices by
-    modernising the premises, information processing and assessing systems and office
     management,
-    creating conditions which will attract talented, qualified, trained and motivated
     personnel to work in these office.
-    empowering the employees in the patent offices and raising their level and stature;
     and
-    ensuring early and timely grant of IPR.

introducing attractive fiscal incentives and mechanisms to enhance and encourage patenting of inventions overseas.

launching a massive programme on creating digital data bases on traditional knowledge, so that `prior art’ could be easily established.

creating/amending IPR laws to protect national interests while meeting the international obligations

Judiciary and legal system would need to :

devise and provide mechanisms for quick and effective disposal of legal cases.
provide for registration of Patent Attorneys and form a Council for maintaining high professional standards.

Industry would need to:

enhance skills to understand, analyse and manage IPR as a means for corporate strategy.
scout and seek alliances with sources of IPR for market positioning.
transact and treat IPRs as any other tangible property.
spearhead formation of a National Association of Inventors to foster inventiveness and to provide a forum for inventors to meet together.

S&T system would need to:

stimulate and encourage creativity and inventiveness of their employees.
promote awareness of IPR and the importance for its protection.
develop skills to understand, interpret and use the techno-legal business
information contained in patents.
facilitated access to international IPR and information databases.
capture and assess the intellectual property generated at an early stage.
recognise and reward inventiveness.
develops skills to manage and exploit IPR.

Educational system would need to:

devise appropriate curricula on IPR and introduce these as formal courses at school, graduate and post graduate levels.
develop qualified manpower to draft and interpret patents and other
IPRs.
provide refresher training to practising IPR professionals.
carry out research on IPR to further its knowledge and use.

17. Amendments to patent legislation

A key indicator of the success of R&D efforts in the ultimate analysis is the return expected from the R&D both to the innovators and to the society. The intellectual property created from the R&D and its use for creating wealth and social good is a key step in this entire movement of mind to market place.

A TRIPS compatible IPR legislation, which at the same time protects the interest of consumers and allows a platform for the growth of Indian pharma industry would need to address the following issues:

Patentability : Product patent should be granted in India for New Chemical Entity, including new chemical molecules and new chemical formulations only. However, in order to ensure that the legislation remains TRIPS compatible, Section 3 of the present Patent Act, which denies patentability to formulations of drug molecules would need to be re-examined. In order to ensure that only novel drug delivery systems enjoy the benefit of process patents, platform technologies capable of application to extend drug usage, patient compliance and convenience should be covered in the description of patentability. The terms of novelty, inventiveness and utility could be illustrated and their limits clearly laid down.

Compulsory licensing : Provisions of compulsory licensing are required to prevent misuse of exclusivity, which results out of grant of a product patent. It is recommended that :

Our law should clearly articulate the provisions to avoid conflicts in future.
Conditions under which the patent holder’s rights may be restricted or cancelled in public interest are to be defined.
The patent office should have right to grant a licence where Controller is reasonably satisfied that the patent holder had abused the exclusivity.

-   Legislation should specifically articulate the abuse of exclusivity. For this some of the
    reasons could be:
-   Inability to meet product demand through importation on reasonable terms.
-   Conditions attached by a patent holder for supply of the product and /or grant of a
    licence for production, which may not be fair.
-   Refusal for grant of a licence by the patent holder, which adversely affects the Health
    Policy or export or development activity after the period of information exclusivity.

The licence may be granted at least after three years of the grant of a patent or four years after the submission of a patent application, whichever is later.
The law must provide only for a reasonable period to enable the patent holder to respond before the Controller proceeds to grant a licence.
The Compulsory Licence should be non-exclusive and non-assignable, which would imply that the Controller has a right to grant more than one licence. The requirement of the waiting period may be waived by the Controller in the case of a national emergency or circumstances of extreme urgency or in cases of public non - commercial use; however, the patent holder shall in such circumstances be notified as soon as reasonably practical (TRIPS article No.31).

Public interest : Keeping public interest in mind, certain acts must be clearly discouraged. These would include charging exorbitant prices, contributing to artificial shortages and failure to supply drugs at the quality expected by the health authorities. Any of these acts, either by the Patent holder or his licensee, must immediately attract severe penalties. The Controller of Patents in such cases, must be required to move in swiftly for invoking the compulsory licensing provisions recommended by the Committee.
Developmental activity : It is recommended that the Patent Law should provide for undertaking research and developmental activity including clinical evaluation, production processes/methods development and regulatory approvals by persons other than the patent holder during the patent life. Such activity which is related to development and submission of information (including samples/exhibition batches) may be deemed as non-commercial activity and would cover developmental activity which is aimed at seeking approvals/registration of the subject molecule.
Patent life : Article 33 of the TRIPS provides for a minimum period of 20 years to be the period of protection of all patents. An International practice, over the years, has been developed, which permits the patent holder to extend the life of their product patent by introducing new usage applications or new dosage forms or a new presentation for a product already in public domain. There are also no TRIPS defined measures such as regulatory delays, non-consideration of regulatory applications, limited industrial application extension etc. on the grounds of which such extensions up to period of 5 years have been granted in various countries. It is recommended that the Patent law should not provide any features that are not available in TRIPS for providing extension of patent life beyond 20 years from the date of filling of the patent application.
Working of a patent : In a country like India with its large population and tropical disease pattern, exemption available under TRIPS for public health requirement should be availed of. Failure to manufacture in India could be considered as a misuse of compulsory licensing.

Opportunities for success abound, but will be claimed by competitors who have vision, confidence and resolve to embrace them.

The pharmaceutical Industry into its Second Century
From Serendipity to Strategy
The Boston Consulting Group

X. REGULATORY FRAMEWORK

18. Status

It is the sovereign function of the government to ensure safety, efficacy and quality of drugs supplied to the public. This function is performed by the Central Drugs Standard Control Organisation (CDSCO), DGHS, Ministry of Health and Family Welfare with the Drug Controller General of India (DCGI) as the executive head.

The role of CDSCO in early stages of drug development is minimal but it becomes more pronounced consequent to the lead obtained from animal pharmacology and toxicological studies and the need for its further testing on humans. The requirements of data submission on animal testing for permission to undertake Phase I, Phase II and Phase III clinical trials are laid down in Schedule Y of Drugs & Cosmetics rules. The relevant data submitted to the DCGI is evaluated with the assistance of expert clinicians/scientists. Similarly for registration and approval of new drugs, which have already been registered and used in the country of origin, Phase II trials in about 100 patients is usually insisted upon by DCGI before allowing such products to be marketed in India. Normally new drug approval is initially granted for a period of 2 years. At present the firms are directed to conduct PMS studies during this period in order to further ensure safety of such drugs. It is envisaged that clinical trials are conducted only after clearances are obtained from Institutional Ethical Committees. Consent of patients for participation in such trials is an integral part of the regulatory framework.

19. Need

With International Conference on Harmonisation (IHC) coming into existence in 1991, there is a strong trend towards globalisation of regulatory and scientific requirements pertaining to safety, efficacy and quality issues. However, the evaluation of massive scientific and technical data and various clearance processes demand recourse of multi-disciplinary expertise from clinical, pharmaceutical and scientific fields. The manpower and infrastructure facilities of CDSCO has unfortunately not kept pace with these demands. A professionally managed and efficient regulatory mechanism under CDSCO will ensure that the products based on R&D in India are readily acceptable to the medical profession in India and overseas. Accordingly it is essential that :

full-time experts in key areas with adequate scientific and medical expertise and back-up support should be made available to the DCGI.
a time schedule for processing of application for different stages of clinical trials should be developed and made known by the DCGI along with the fees to be charged for different stages.
units of the DCGI may be assisted by expert panels for each activity disease -wise for drafting of the testing protocols.
the fees at each stage of trial should be charged for processing an application.
a strict programme schedule should be adhered to, that could be : (i) IND Phase I – within 3 months, (ii) IND Phase II – within 6 months, and (iii) marketing approval – within 3 months.
the responsibilities of post marketing surveillance should also be with the regulatory authorities and not with the R&D institutions or pharma companies.
Adverse Drug Reaction (ADR) monitoring should be of high quality done through a special unit manned by experts and this should be made available to the CDSCO office.
On a priority basis, the office of the DCGI should be provided with electronic networking nationally and internationally to facilitate and expedite decisions.
an Advisory Board may be set-up to advise the DCGI regarding the protocols for drug testing and for policy development in order to strengthen the knowledge base of this office.
A cGMP on the lines of US FDA to recognise quality manufacturing practices needs to be instituted by DCGI.

To facilitate the above, a new structure for CDSCO needs to be designed. Accordingly, a new structure of CDSCO as depicted in fig. 4 is recommended for implementation. A more detailed note considered by the committee is at Annexure 4, which provides a rationale for such a structure and also provide the broad context.

Fig 4. PROPOSED STRUCTURE OF CDSCO

(In respect of new approvals)