Indian Pharmacopoeia Commission
In a move to strengthen the Pharmacovigilance Programme of India (PvPI) in the North East (NE) region, the Indian Pharmacopoeia Commission (IPC) recently had a co-ordinators meet with all officials from its eight adverse drug reaction monitoring centres (AMCs). The meeting focused on discussing issues and challenges faced by the officials while reporting ADRs from states of Assam, Tripura, Meghalaya, Manipur and Sikkim.
Experts stressed that considering the importance of ADR in the success of the PvPI programme, pro active steps should be taken to streamline the activity by creating better awareness about the same among the people so that they will be encouraged to participate in the same. Dr V Kalaiselvan, senior scientific officer from the IPC informed that going in this line, the coordinators were directed to coordinate with the health departments in the rest of the NE states such as Nagaland, Mizoram, Arunachal Pradesh in reporting of ADRs.
In fact it is understood that Dr Y K Gupta, national scientific coordinator, emphasised that there is a need for strengthening PvPI for better reporting. There are a total three AMCs in Assam; two in Tripura; one in Meghalaya, Manipur and Sikkim each. The AMCs from NE, which had started reporting ADRs to NCC since 2011 have contributed approximately 3.5 per cent of the data to PvPI database till now. In fact, National Coordination Centre (NCC) provides all kind of logistic and technical support to the AMCs in NE to ensure medicines safety.
In fact the Commission, which is the NCC for the PvPI has already started streamlining their activities by organising continues medical education (CME) programme in collaboration with North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), which is the AMC, in Meghalaya. Interestingly this is the first time IPC is conducting CME, which is a training programme in the NE region.
It highlights the proactive measure IPC is taking towards generating awareness and interest about ADR among the healthcare professionals, which includes clinicians, pharmacists, nurses, officials from the health department, government of Meghalaya, co-ordinators of NE AMCs.
According to Dr Kalaiselvan, “These initiatives are mainly aimed at strengthening the PvPI programme so as to generate a strong data base that will help in addressing the healthcare issues relating to use of drugs. Effective and timely ADRs play a vital role in the success of PvPI programme, thus understanding the different pattern of reporting is also very essential, as the adverse reactions change as per the ethnicity of the region. Thus getting more AMCs under the PvPI and training them is very essential to understand and generate a strong data base which is unique to the region.”
Humane Society International (HSI) India expressed relief and hope over the Drugs Controller General of India (DCGI) decision to contemplate over possibilities of replacing drug testing on animals with alternative no animal testing methods. It is understood that the Central Drugs Control Organisation (CDSCO) is giving serious thought on modernising India’s pharmaceutical safety assessment by replacing old-fashioned animal testing with modern non-animal alternatives.
The association applauded and stressed that the visionary approach to science adopted by the DCGI is appreciable, as nine out of ten experimental drugs that appear safe or effective in animal tests go on to fail in human patients because there are simply too many biological and physiological differences between the species for these methods to be reliable. Thus we strongly believe that the approach taken by Dr G N Singh who is the DCGI of the country will contribute for the greater good of the patients and animals alike.
According to Alokparna Sengupta, research and toxicology campaign manager, HSI India, “Dr Singh is showing visionary leadership in his efforts to implement transformational change in India’s science infrastructure. Moving away from outdated and unethical animal tests and aligning India’s pharmaceutical regulations with those of other leading economies is a step forward for human health, industry and animals alike. HSI has successfully worked with governments and scientists across Europe, North America and beyond, and we look forward to working with Dr Singh’s office to advance 21st century safety science in India, too.”
It is understood that with an aim to curb the misuse and torture of animals used for animal testing the DCGIs office is working very hard with the Indian Pharmacopoeia Commission (IPC) to replace some of the existing monographs with the alternative modern methods which includes sophisticated tests using human cells and tissues known as ‘in vitro’ methods. While serious thought is also given to adopt advanced computer-modeling techniques referred to as in silico models, and studies with human volunteers.
Humane Society International India has been actively advocating non-animal test approach for many years and have been conducting series of workshops and conferences across India, presenting the expertise of international scientists in modern chemical and pharmaceutical toxicity testing. One of such test is the Tox21’ the transition to high-tech, human biology-based safety testing that was recently discussed at a science workshop in Hyderabad by HSI’s president Dr. Andrew Rowan.
The Drugs Controller General of India (DCGI) is seriously contemplating to explore the possibilities of replacing drug testing on animals with alternative no animal testing methods. This move aims at curbing the misuse and torture of animals used for animal testing and for safeguarding their interests as ethically required.
In lines with this, the drug controllers office is working very hard with the Indian Pharmacopoeia Commission (IPC) to replace some of the existing monographs with the alternative modern methods which includes sophisticated tests using human cells and tissues known as ‘in vitro’ methods. While serious thought is also given to adopt advanced computer-modeling techniques referred to as in silico models, and studies with human volunteers.
Dr G N Singh, DCGI informed that since new technologies are available with immense potential to provide conclusions even more accurate than those from animal testing, serious thought should be given to encourage gradual withdrawal of use of drug testing on animals whenever possible. He further stressed that it is with this vision that the Central Drugs Control Organisation (CDSCO) has dedicated the 2014 as ‘patient and animal safety year
“We envision to protect the lives of all the living beings in the country and for that all steps will be taken pro-actively to enhance good governance by strengthening regulatory mechanism further. We understand that experiments on animals are unethical and cruel and we are going to make sure that all steps are being taken to avoid cruelty against animals by ensuring stringent adoption of good laboratory practices (GLP) in all the manufacturing units across the country and also while conducting clinical trials etc,” Dr Singh pointed out.
Interestingly, in a landmark decision, India become the first country in South Asia to ban animal testing for manufacturing cosmetics last year. The Bureau of Indian Standards (BIS) is now required to set down standards to meet the new requirements while the DCGI will make relevant amendments in acts and laws.
The seventh edition of the Indian Pharmacopoeia (IP 2014), officially released in November last year by the Indian Pharmacopoeia Commission (IPC) has come into force in the country with no further extension of its implementation by the regulatory authorities.
The IP 2014 is presented in four volumes. The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a days are omitted from this edition.
As per the original plan, the IP 2014 was to come into force from January 1, 2014. But, there were demands from industry to postpone the implementation because of the practical difficulties. This has prompted the Indian Pharmacopoeia Commission to delay the implementation, giving more time to the industry to adopt the changes.
Meanwhile the IPC has received inputs from its stakeholders on IP 2014 which require up-gradation/changes. The IPC has issued draft amendments (proposed) and has invited comments/suggestions from the experts and stakeholders within 30 days.
The IP 2014 incorporates 2548 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms, antibiotic monographs, insulin products and herbal products etc. 19 new radiopharmaceutical monographs and 1 general chapter is first time being included in this edition. It is hoped that this edition would play a significant role in improving the quality of medicines which in turn promote public health and accelerate the growth and development of pharma sector.
The IP-2014 is published in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder and it prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines.
In a strategic development, the Indian Pharmacopoeia Commission (IPC) which acts as the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI) informed that the country’s contribution to WHO-UMC global safety database has increased up to 2 per cent in 2013.
According to the Commission, the contribution of the country in the year 2012 was 0.5 per cent, which in 2013 rose, making India as the seventh largest contributor among other member countries participating in the WHO Programme for international drug monitoring. According to Dr V Kalaiselvan, senior scientific officer from the IPC India is the fifth largest country in Asia and seventh in the world for its contribution in reporting highest percentage of ADRs to global safety database.
World Health Organisation‘s (WHO’s) Uppsala Monitoring Centre (UMC) in Sweden, which is WHO’s collaborating centre for international drug monitoring, contains the received individual case safety reports (ICSRs) from its 117 official member countries. Interestingly, IPC also has access to the ADR data from the UMC, which enable them to have access to data on international adverse reactions to drugs, to formulate drug safety measures within India.
It is understood that, WHO has developed a common reporting form with agreed guidelines for entering information in a compatible systems for transmitting, storing, retrieving and disseminating data to formulate an effective international system on ADR .The UMC works by collecting, assessing and communicating information from national pharmacovigilance programmes of their member countries in regards to the safety, efficacy an d risks-benefits ratio associated with the drugs.
India became member of WHO–UMC international drug monitoring programme in the year 1998 and since then India is continuously contributing to global safety database. In 2005, India was engaged in pharmacovigilance activities by starting up the ‘National Pharmacovigilance Programme’, but this programme was not able to generate sufficient data in order to identify the signal and after few years was stopped. To address the lacunae, in July 2010, a new pharmacovigilance programme called the PvPI was launched.
“This present programme has been structured taking into consideration the past deficiencies. Under NCC-PvPI, India’s contribution of ICSRs to global safety databse i.e Vigibase is approximately 78,000 ICSRs, this data is sufficient for signal detection and making important regulatory recommendation regarding the drug safety. In future, India is expected to achieve such operational efficiencies that would make our PvPI Programme a benchmark for global drug monitoring,” Dr Kalaiselvan informed.
IPC has undertaken a lot of efforts to enhance ADRs reporting, like establishing ADRs monitoring centres across the country, integrating with national health programme like revised national tuberculosis control programme (RNTCP) and adverse events following immunisation (AEFI), coordination with pharma companies etc. Recently the IPC had also upgraded its existing helpline facility for providing assistance in timely reporting of ADRs by introducing the SMS acknowledgement service.