What ails IPC?
Ever since its inception, Indian Pharmacopoeia Commission (IPC) has always been like a square peg being forced into a round hole. Lack of funds, infrastructure and bureaucratic hassles continue to pose challenges at IPC, Sushmi Dey discovers …
“Nobody can stop an idea whose time has come,” said Surinder Singh, DCGI, while addressing the audience during the launch of the new Indian Pharmacopoeia 2007. Indian Pharmacopoeia (IP) is one such idea which is expected to make a difference to the Indian pharmaceutical industry. Undoubtedly, setting up of the Indian Pharmacopoeia Commission (IPC) was a major and significant step towards the goal. Yet, even after the launch of the first pharmacopoeia after setting up of the IPC, industry sources say that there are bureaucratic and policy hurdles stopping the idea from taking perfect shape.
While the Indian Pharmacopoeia 2007 was recently launched in Delhi in the presence of new DCGI, Surinder Singh, former DCGI, Dr M Venkateswarlu and other eminent scientists, stakeholders, industry learders and members of Indian Pharmacy Graduates’ Association (IPGA) and IPC, various outlooks on the pharmacopoeia and IPC came to the forefront. Although IPC was appreciated and congratulated for its success in bringing out the new edition of IP, members of IPC were divided on their opinions and there were objections to frequent bureaucratic interventions in the working of the Commission. As a matter of fact, the Vice-Chairperson of the scientific committee of IPC, Dr P R Pabrai, resigned almost a year back due to such problems. Although his resignation has not yet been accepted, Pabrai and many other IPC members continue to have major differences with the government.
No wonder, one of the members addressing the launch said, “IP 2007 is a milestone on a long and arduous journey to success but let us not get intoxicated.”
Surinder Singh, Drug Controller General India lights the traditional lamp
Release of the Indian Pharmacopoeia 2007
It took almost two years for IPC to come up with the new IP 2007. IPC was set up in March 2005 by the Ministry of Health and Family Welfare, Government of India. Earlier, the Indian Pharmacopoeia Committee, through sub-committees and experts from academia and industry, was regularly updating the IP. Since IP committee was part of Ministry of Health and Welfare, experts from industry conceptualised the idea of having an autonomous body for updating the pharmacopoeia on a more regular basis. Though, the decision to have an independent Pharmacopoeia Commission was taken by Drug Technical Advisory Body in 1982, it was in 2001 that the government gave it the green signal. “IPC was finally constituted in March 2005 and actually started working in mid 2006,” informs Prem K Gupta, member of the scientific committee and former Drug Controller (India).
IPC is an autonomous body under the provisions of Societies Registration Act, 1860. However, the Commission, which was formed with great promises, is still struggling for want of funds and autonomy in real life. According to IPC members, it has been a very tumultuous journey for them since inception. “IPC was formed as part of a parliament act and this was created as a registered commission. The preamble said that IPC will be an autonomous body, and hence, the agenda of government should be to have some eminent scientist as a chairman, but the government has not done that,” complains Gupta.
The IPC was formed with the main objective of publishing journals and publications related to pharmacopoeia on a regular basis. The IPC was also meant to ensure easy procurement and supply of reference material. The Commission is also instrumental in bringing in harmonisation with international pharmacopoeia while making attempts to retain an Indian identity.
The IPC has a three-tier structure consisting of a governing body, general body and a scientific body. According to G N Singh, Secretary and Scientific Director, IPC, there are eight to ten members in the governing body, 19 members in general body and 15-23 members in the scientific body of IPC. “While the scientific body meets regularly and provides guidelines, the general body meets once in a while to look into matters brought in by the scientific body. Recommendations from the general body go to the governing body, which is chaired by Secretary, Ministry of Health and Family Welfare. All final decisions related to policy, budget and posts to be sanctioned are taken by the governing body,” explains Gupta.
What is the need?
While standard pharmacopoeias like US Pharmacopoeia (USP) and British Pharmacopoeia (BP) already exist, why do we at all need a pharmacopoeia of our own? “Indian pharma industry consists of various types of players. There are big players like Ranbaxy, Dr Reddy’s Laboratories and Lupin etc who have the mechanism and the money to adapt to testing methodologies and quality standards set by USP and BP, but there are also medium and small size players in the Indian pharma industry who cannot afford it so intrinsically. The aim of IPC is to develop such a gateway through IP which can facilitate medium and small size pharma companies. We need standards which are affordable to our manufacturers,” said Pabrai on the sidelines of the launch of IP 2007.
Pharmacopoeia is a book in the form of a compilation of technical information on standards for Active Pharmaceutical Ingredients (APIs), drug products and associated testing techniques for the evaluation of quality. It needs a dedicated team of professionals to make changes in the face of rapidly changing trends in the pharma industry and science. Though pharma companies undertake stringent procedures to check and ensure quality, there should be an authority, which sets the standards. The IPC plays the adjudicator in this respect. “Indian Pharmacopoeia is produced in fulfillment of the requirements in the Drugs and Cosmetics Rules, 1945 for standards of drugs produced and/or marketed in Indiam, and thus, contributes in the control of the quality of the medicinal products. The standards of this pharmacopoeia are authoritative, legally enforceable and intended to help in the inspection and licensing of manufacturing and distribution of drugs and pharmaceuticals,” asserts Singh.
Undoubtedly, IP and IPC are both significant for the Indian industry to go international. The job requires an independent body with dedicated and technically qualified members to review and update the national pharma-copoeia on a regular basis. “India has proved that it is capable of having standards of its own for pharma companies. India has done it right from the beginning and IP 2007 is a unique example where industry, academia and regulatory people came together to perform a tremendous work,” said Venkateswarlu while congratulating IPC on the launch of IP 2007. A proper strength, well developed infrastructure and adequate funds are some essential requirements for IPC to be able to bring timely and regular publications of IP.
They say that promises are made to be broken. So say the members of IPC too. IPC has already faced challenges and crossed many hurdles but there are more in the pipeline. When the commission was formed, great promises were made and the members were upbeat about the entire project, but now it seems IPC is facing many challenges, primarily for lack of funds and autonomy.
The three-tier structure of IPC which was designed as a facilitator proved to be too complicated for its members. The commission is now striving for funds, employee strength and power to take independent decisions. According to IPC members, with a bureaucrat as the Chairman of IPC it has been reduced to yet another government run body where there is no administration and financial autonomy. “IPC was formed with promises to be a self-sustained body with independent decision making powers, but it is not functioning like that. There is a bureaucrat sitting on board who does not understand scientific matters,” complains Pabrai. Agrees Gupta, “The three-tier structure should act as a facilitator and not a stumbling block.”
According to Pabrai and many other members of the society, an eminent scientist should be made the Chairman of IPC who can understand the needs and requirements of the scientific community and work for its betterment. “Pharmacopoeia and work related to it is a scientific matter, and hence, a scientist will take a different view. A bureaucrat cannot have that. With an eminent scientist as Chairman, IPC can have independent budget according to scientific needs and can also take relevant decisions independently. We also need staff that understand science and infrastructure in place,” says Gupta.
IPC also lacks proper infrastructure and staff. The IPC is headquartered at the Central Indian Pharmaco-poeia Laboratory (CIPL) at Ghaziabad and uses the same lab for developing standards. However, the lab does not have complete infrastructure required for pharmacopoeia work. “The CIPL lab was a testing laboratory and we need separate lab for producing reference substance,” says Gupta. He adds that the CIPL lab was also promised more staff, which again has not happened so far. As a result pharmacopoeia work took too much of time. “There are challenges like creating infrastructure, produce reference substances and have adequate manpower. To do dedicated work we need more people with financial and technical autonomy,” adds Gupta.
Light of hope
Inspite of all the challenges and hurdles, IPC has successfully launched the new pharmacopoeia 2007. This pharmacopoeia is effective from April 2008. According to Singh, IP 2007 is made in a user friendly format with three hard bound volumes. Cross referencing has also been avoided in the book. “The new IP has a total of 1500 monographs. Veterinary products monographs are an integral part of this edition. We have taken special care to provide uniformity of presentation of subject matter,” says Singh. Category of a drug, dosage and usual available strength of dosage forms are also omitted from the new IP. “Classical chemical tests for identification of an article have been almost eliminated and more specific IR and UV spectrophotometric tests have been introduced. Use of chromatographic methods has been greatly extended to cope with the need for more specificity in assays. However, test for pyrogens are virtually eliminated,” informs Singh.
The new IP also contains several new monographs that are not there in any major pharmacopoeias of the world. For instance, monographs on antiretroviral drugs and herbal products are available in no other pharmacopoeia. Scope of pharmacopoeia has also been extended to include products of biotechnology, indigenous herbs, vaccines and commonly used fixed dose combinations.
Besides, herbal drugs monographs also contain photographs. Authenticity certificate bearing the IPC seal and book number is also a unique feature introduced for the first time in the new IP 2007. However, the cost of the IP is Rs 15,000 per set, but IPC is of the opinion that it is not too expensive as there some sophisticated standards included in it, which are not there in any other pharmacopoeia. Also, it involves a lot of hard work with inadequate infrastructure and funds available.
However, there are several plans in IPC’s pipeline. It has already signed MoUs with USP and BP to promote greater co-operation through the exchange of information and to increase awareness on the quality and safety of medicines. There are also talks going on with pharmacopoeia commissions of France, Europe and WHO on signing similar MoUs.
IPC also plans to develop a well equipped lab and suffient manpower to meet deadlines in future. “The commission also targets to publish the first addendum with corrections and errors by December 2008 and a new pharmacopoeia will be published every five years from now,” says Gupta.
Besides, members of IPC are hopeful that after this successful job things will improve in near future. “IP should be seen as a yard stick of quality. We are to create a benchmark. Pharmacopoeia will help in doing so. Quality in IP is a non-negotiable commodity. It creates excellence,” said PD Sheth, member of IPC and former President of IPA during the launch. Sheth also requested DCGI to supervise the implementation of pharmacopoeia.