Indian Pharmaceutical Association (IPA) is organising the biennial ‘Nasal and Pulmonary Drug Delivery’ symposium on October 24-25, 2013 in Mumbai. This time’s theme is ‘Global Regulatory Trends’ with a focus on Asia, LATAM, South Africa and European markets apart from the US market. Aptar Pharma is the principal sponsor and co-organiser for the event. Scheduled to present at the event, Dr Amit Misra, Scientist and Associate Professor AcSIR, CSIR-CDRI and Dr Julie Suman, President, Nextbreath LLC speak to Usha Sharma highlighting regulations and market potential of this sector, the key topics to be discussed at this event
Globally, what are the regulations for nasal and pulmonary drug delivery system? And does India follow similar regulations or are there a different set of regulations in place?
| Dr Julie Suman |
Dr Julie Suman (JS): The US, EU and Brazil have the most defined requirements for these dosage forms. In my experience, we’ve worked with Indian companies looking to bring products into more regulated markets than India. So they are naturally following these regulations. Within India, the regulatory expectation is less.
| Dr Amit Misra |
Dr Amit Misra (AM): Central Drugs Standard Control Organization (CDSCO) has recently announced the guidelines under Penal Provision for what it calls Category A Defects as follows:
- Aerosols/ Inhalations: Assay below 70 per cent for thermolabile products and below five per cent of the permitted limits for thermostable products.
- Leak test: With reference to the existing regulations, the provision of 10-year jail terms and fines of millions of rupees is intended as a deterrent to unethical practices. This, in my opinion, is far more stringent in scope, if not necessarily in application, than almost any other regulated market that I am aware of.
Do you think developing countries should have a different set of regulations for nasal and pulmonary drug delivery?
JS: I think that the concept of harmonisation for all countries is most beneficial for all and ultimately the most cost effective. As the Western world’s consumer buying power decreases and the need for affordable healthcare increases, it facilities India’s ability to enter other markets. Harmonisation provides a level on continuity within India as well. However, I believe there is room to select which tests are most appropriate for a given country.
AS: Yes, I strongly advocate a more pragmatic regulatory regimen for countries such as mine. I suggest that the Western countries have regulated themselves into a highly restrictive situation, discouraging small and medium manufacturers from production and distribution of medicines. I feel that this situation has arisen partly because of inputs given to regulatory agencies by interests supporting large pharma corporations. I believe that the appropriation of the word ‘Good’ in respect of Organisation for Economic Co-operation and Development (OECD) and other guidelines on laboratory, manufacturing and clinical practices is overly presumptuous. There is nothing inherently ‘good’ about GLP, cGMP or GCP– the documents merely present a way of doing things that is obsessively focused on keeping records, mathematising observations and following routine procedures. I think that we in India should jettison the entire concept of ‘good’ practice driven regulation, and approach the problem of assuring quality of medicines in the marketplace using an approach that addresses intent, ethics, exigency and appropriate technology.
Will nasal and pulmonary drug delivery system be the next important area for Indian pharma companies?
JS: The best way to treat locally acting conditions such as allergies, asthma and chronic obstructive pulmonary diseases (COPD) is by these routes of administration. So certainly this is an important area for development.
AS: Not the single ‘next’ important area, but certainly for asthma and COPD, as well as in a limited way for cystic fibrosis and tuberculosis. Therapeutic peptides and vaccines administered by nasal or oro-pharyngeal inhalation are likely to find interest in the industry setting.
Besides India, which other markets have the potential for this therapeutic and why?
JS: Cost effective medication will become important globally which opens the door to almost any market.
AM: I don’t know much about markets, but patients are certainly in need of good inhalation products worldwide.
What are your suggestions/ changes for the Indian nasal and pulmonary drug delivery system
JS: I would turn that question around. What can we learn from India? The concept of a single dose system such as purchasing a single tablet is quite common in India. Nasal and pulmonary products typically contain 30 or more doses. Development of delivery systems that contain fewer doses is both a challenging and interesting area.
AM: I suggest that we work on making cheap inhalation devices, avoid unessential add-ons like fancy shapes, dose counters, blister-reels, etc., and favour powders filled in hard capsules rather than MDI. The only reason why DPI are more expensive than corresponding pMDI is device costs, which, in my view, are inflated far beyond research and production costs.