Work in progress?

Work in progress?

Indian Pharmacopoeia is unlike its American and British counterparts and is still struggling for freedom and autonomy. But many critics say that it is still in its infancy and offers great promise. Sapna Dogra investigates

Indian pharma is going international. Yet there are some aspects of the Indian industry, which are not quite up to the international standards like the Indian Pharmacopoeia (IP). There are varied outlooks on the pharmacopoeia. While some people say that it’s the bureaucratic hassles that are slowing down the work, some feel that it still is on the growth path. But all agree that a lot is yet to be done in this area.

A brief history

It has been over a year since the Government of India, Ministry of Health and Family Welfare set up the Indian Pharmacopoeia Commission (IPC). However, the commission, which was formed with great promises, is struggling for want of funds and autonomy. Since inception, it has been a very tumultuous journey for the Indian Pharmacopoeia Commission. Going back in history, a decision to have an independent Pharmacopoeia Commission was taken by Drug Technical Advisory Body in 1982, but it was in 2001 that the government gave it green signal. Earlier, the Indian Pharmacopoeia committee, through sub-committees and experts from academia and industry, was doing the regular updating of IP.

“We shouldn’t and can’t adopt the British Pharmacopoeia or US Pharmacopoeia
because our industry has not reached that stage. We need standards, which can be managed by our manufacturers”

– Dr Pabrai Vice-Chairperson

Scientific Committee-IPC

The main objective of the IPC is to publish journals and publications related to pharmacopoeia, ensure easy procurement and supply of reference material. It also works towards international pharmacopoeia harmonisation and attempts to retain the Indian identity. According to Dr Nityanand, an eminent scientist and the Chairperson of the 23 member scientific committee of the IPC, “Indian pharma industry is very complex with small, medium, large and very large pharma players in the arena.” Big players can afford testing methodologies and quality standards of the US Pharmacopoeia (USP) and British Pharmacopoeia (BP), but small and middle level player can’t afford it so intrinsically. And IPC is all about Indian standards. “We shouldn’t and can’t adopt the BP or USP because our industry has not reached that stage. We need standards, which can be managed by our manufacturers. For instance, UK can use the NMR technology but our people can’t afford it,” says Dr Pabrai, Vice-Chairperson, Scientific Committee of the IPC.

What is pharmacopoeia?

Pharmacopoeia is a compilation of technical information on standards for active pharmaceutical ingredients, 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 pharmaceutical industry and science. Though pharma companies undertake stringent procedures to check and ensure quality, there should be an authority, which sets the standards. The Indian Pharmacopoeia Commission plays the adjudicator in this respect.

IPC is of paramount importance because the pharma industry needs an independent body to review and update the national pharmacopoeia on a regular basis. For this, it requires adequate strength of technically qualified personnel and well-developed infrastructure to include large number of new drugs and their combinations, which are coming into the market at a rapid pace. With the establishment of the IPC, timely and regular publications of IP would benefit both the industry and the regulatory authorities.

  • US Pharmacopeia was founded in 1820. Way back then, a merger 217 drugs were admitted
  • The regulation of medicines in UK existed ever since the reign of King Henry VIII ie 1491-1547. London Pharmacopoeia published in 1618 and the first edition of the British Pharmacopoeia was published in 1864
  • The Society of Japanese Pharmacopoeia (SJP) was established in June 1956 to provide information regarding the proper use of drugs
  • The World Health Organisation maintains the International Pharmacopoeia to maintain global uniformity of quality specifications

Bureaucracy rules

When the commission was formed, the members were upbeat about the entire project. It was believed that the commission would be more autonomous and would not have to refer to other groups to get issues sorted out. However, it seems the three-tier structure is proving to be a stumbling block than a catalyst in the working of the IPC. Three-tier body consists of the governing body, the general body and the scientific body.

“The IP Commission was supposed to be a self sustained body with independent decision-making powers, but it has been reduced to yet another government run body with clique of bureaucrats on board and no administration and financial autonomy,” says Pabrai. Agrees R S Iyer, Member Scientific Committee of IPC and says, “For one, it’s been made a very complicated structure with three tiers where things are moving at a tardy pace.” The problem is it is not a priority with the government and hence it’s been put on the back burner, bemoans Pabrai. According to another IPC member, as per the notification, an eminent scientist should have been the chairperson of the general body and governing body, but actually a bureaucrat has been made the chairperson.

The IPC were to use the Central Indian Pharmacopoeia Laboratory (CIPL) at Ghaziabad for developing standards. However, the work has been going on at a very slow pace. “The CIPL Ghaziabad was to handle all the pharmacopoeia work but it is still saddled with lot of drug control work. Hence, it is not being able to devote time for pharmacopoeia work,” rues Iyer. He adds that the CIPL lab was also promised more staff, which again has not happened so far. As a result pharmacopoeia work is going slow. Iyer sums up that IPC needs the financial and technical autonomy along with adequate manpower.

What next?

The next edition of Indian Pharmacopoeia is due for 2007. “However, the way things are moving, I doubt that it would be able to come out on time,” observes Iyer. The Indian pharmacopoeia committee published the last edition of IP in 1996 and two addenda were also brought out. “Of course, it is a Herculean task as there are about 2,500 drugs to be monographed. With no infrastructure, absolutely no funds and manpower, it is a challenging job,” says Pabrai. Incidentally, the cost of an IP is Rs 5,000.

The commission expects to revise the IP every five years supplemented with addendum each consecutive year, informs Pabrai. He adds that though the scientific committee is working on it, they are cash strapped because IPC has no financial independence. The members are demanding autonomy of finances, administration and scientific work. The US Pharmacopoeia (USP) is a non-governmental organisation, which has 600 people working regularly on it and it is a self-sustaining body. Whereas the British Pharmacopoeia (BP) is a government body having a scientist as the chairperson. USP and BP bring out their pharmacopoeia every year.

On the brighter side

From an optimistic angle, IPC has also made a number of strides as well. “Of course things can always be bettered and can be improved further but let’s not undermine the progress we have made so far and achievements we have got,” says Nityanand. ICP has had built a rapport and associated with industry bodies like IDMA, which is a positive step. And there are industry representatives present in the scientific committee. Also, IPC has signed an MoU with United States Pharmacopeial Convention to promote greater co-operation through the exchange of information and to increase awareness on the quality and safety of medicines. Hence, Nityanand feels that things are looking up.

ICP is still in its formative stages and teething problems at this stage is normal. Nityanand feels that the scientific body meets every three months and so far, three meetings have taken place. The next meeting is due on the first week of October this year. “By 2007, we will definitely bring out the next edition of IP. And every five years, we will come out with a new edition,” Nityanand prophesies. The last addendum included many products that were not there earlier. For example, it has 29 monographs of anti-AIDS drugs, 20 of which do not exist in any other pharmacopeia in the world.

Some prospects

Moreover, the government has agreed in principle to dedicate CIPL Ghaziabd to IPC and it should become operational soon. “Our aim is to create and change CIPL to a first class pharmacopeia laboratory and I am hopeful that things will change and whatever we have achieved is no mean task,” says Nityanand.

Concedes Dr G N Singh, Director, CIPL and Secretary-cum-Scientific Director IPC. He says that earlier there was some confusion about bureaucratic involvement but that issue has been sorted out amicably when Nityanand has been made the Co-Chairperson of the governing body. He informs that CIPL was granted a fund of Rs 3 crore for renovation and pharmacopoeia work and now it is ready and dedicated to provide logistic, administrative and scientific support to IPC. “By December this year, the next edition of IP would be ready.” Also, the work will start soon on reference substances and we are hoping to have at least 133 reference substances in 2006-07, he adds.