 "US FDA import alerts: Deciphering the right message")
In a span of less than two years, the regulatory hammer has given a throbbing pain to leading Indian pharmaceutical manufacturing companies in India. It needs to be seen that this keeps happening ‘silently’ as well. Many Indian pharmaceutical companies are getting identified by the US FDA at various places in the Indian geography. It can be clearly seen that the US FDA is conducting surprise inspections and taking the Indian pharmaceutical industry completely by surprise. Most of the manufacturing units inspected by the USFDA are producing medicines for the western world and are being inspected for their GMP compliance activities.
The manufacturing plants in India have to adhere strictly to the code of good manufacturing practices (GMP) as per the US FDA guidelines, failing which the US FDA issues a ‘warning letter’ which is then published by the US FDA in the public domain. The US FDA allows the manufacturing unit of the pharmaceutical company to seek compliance within certain stipulated timelines and may even ask the unit to repeat the batch production based on the nature of the deviations in manufacturing standards.
This contributes to a dip in the export earnings of the pharmaceutical industry and also a loss in the ‘credibility’ of the medicines being produced.
The demand of cheap generic medicines in both the developed and developing countries can be seriously affected if the medicines which are for life threatening diseases.
US FDA import warning due to data integrity problems
IPCA is not the only Indian pharmaceutical manufacturer to face the wrath of the US FDA. At least 13 Indian firms have been issued import alerts and subsequent warning letters since May 2013. Most the warning letters have been issued because of the problems of data integrity at pharmaceutical manufacturing facility and US FDA has cited irregularities in the companies’ data integrity practices.
Analysis of US FDA import alerts by country
India and China pharmaceutical companies feature among the maximum number of import alerts for good manufacturing practices. Since 2009, 160 countries have been issued import alerts for violation of good manufacturing practices. The top 30 countries in import alerts contribute to 58 percent of the total import alerts. India and China top the list of import alerts in the USFDA scanner.
The countries, which have the largest number of pharmaceutical manufacturing plants and are the largest suppliers of medicines to the world, have been issued import alerts by the US FDA in the last five years. India ranks fourth in the list of warning letters and import alerts and contributes nearly 3 percent of the total of US FDA import alerts till date. China tops the list contributing a little more than 4 percent, followed by Mexico and Canada which contribute 3.6 percent and 3.5 percent to the total import alerts. The top 20 list of countries in the import alerts features at least 10 countries from the Asia pacific region.
Import alerts on Indian companies
At least seven leading Indian pharmaceutical manufacturers have been issued warning letters and import alerts since 2013. Only half of the year 2015 has passed and the US FDA is rampant on issuing warning letters to the Indian manufacturing units. Needless to say, it is quite likely that more are likely to follow suit. The latest example is Emcure Pharmaceuticals which has received a US FDA ban on manufacturing issues on the 14 July 2015.
Number of Indian pharma companies that received warning letters from US FDA
The road ahead
Needless to say, if the US FDA continues its spree of issuing import alerts on the Indian manufacturing facilities, pharmaceutical producers will have to adhere to the US FDA’s GMP guidelines on a more stringent level. This would mean more quality controls, more checks on the formulation manufacturing processes and rigorous monitoring and documentation as well.
This would mean that Indian pharmaceutical companies would have to incur additional investment in these areas and this would also add to the cost of manufacturing the medicines.
All these aspects has left the largest supplier of medicines (India) at the mercy of the world’s largest consumer and regulator of medicines (USA).
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Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/
The manufacturing plants in India have to adhere strictly to the code of good manufacturing practices (GMP) as per the US FDA guidelines, failing which the US FDA issues a ‘warning letter’ which is then published by the US FDA in the public domain. The US FDA allows the manufacturing unit of the pharmaceutical company to seek compliance within certain stipulated timelines and may even ask the unit to repeat the batch production based on the nature of the deviations in manufacturing standards.
This contributes to a dip in the export earnings of the pharmaceutical industry and also a loss in the ‘credibility’ of the medicines being produced.
The demand of cheap generic medicines in both the developed and developing countries can be seriously affected if the medicines which are for life threatening diseases.
US FDA import warning due to data integrity problems
Rashmi Pant
IPCA Laboratories’ Ratlam unit received an import alert from the US drug regulator on 22 January 2015 for not complying with good manufacturing practices requirements of the US FDA. IPCA Laboratories is a leading manufacturer of pharmaceutical medicines producing greater than 350 formulations and 80 APIs for various therapeutic segments. The title of the import alert given by the US FDA to IPCA Laboratories was known as ‘Detention without physical examination of drugs from forms who have not met the GMPs’ popularly known as DWPE import alert. This is almost always followed by a Warning Letter indicating the extent of the problems at the facility.IPCA is not the only Indian pharmaceutical manufacturer to face the wrath of the US FDA. At least 13 Indian firms have been issued import alerts and subsequent warning letters since May 2013. Most the warning letters have been issued because of the problems of data integrity at pharmaceutical manufacturing facility and US FDA has cited irregularities in the companies’ data integrity practices.
Analysis of US FDA import alerts by country
India and China pharmaceutical companies feature among the maximum number of import alerts for good manufacturing practices. Since 2009, 160 countries have been issued import alerts for violation of good manufacturing practices. The top 30 countries in import alerts contribute to 58 percent of the total import alerts. India and China top the list of import alerts in the USFDA scanner.
Figure 1: Country wise number of import alerts issued by US FDA; Source: US FDA
Figure 1 shows top 30 countries which received import alters issued from US FDA.The countries, which have the largest number of pharmaceutical manufacturing plants and are the largest suppliers of medicines to the world, have been issued import alerts by the US FDA in the last five years. India ranks fourth in the list of warning letters and import alerts and contributes nearly 3 percent of the total of US FDA import alerts till date. China tops the list contributing a little more than 4 percent, followed by Mexico and Canada which contribute 3.6 percent and 3.5 percent to the total import alerts. The top 20 list of countries in the import alerts features at least 10 countries from the Asia pacific region.
Import alerts on Indian companies
At least seven leading Indian pharmaceutical manufacturers have been issued warning letters and import alerts since 2013. Only half of the year 2015 has passed and the US FDA is rampant on issuing warning letters to the Indian manufacturing units. Needless to say, it is quite likely that more are likely to follow suit. The latest example is Emcure Pharmaceuticals which has received a US FDA ban on manufacturing issues on the 14 July 2015.
Number of Indian pharma companies that received warning letters from US FDA
| Years | Warning letters received by Indian pharma companies |
| 2013 | 7 |
| 2014 | 6 |
| 2015 | 2 |
The road ahead
Needless to say, if the US FDA continues its spree of issuing import alerts on the Indian manufacturing facilities, pharmaceutical producers will have to adhere to the US FDA’s GMP guidelines on a more stringent level. This would mean more quality controls, more checks on the formulation manufacturing processes and rigorous monitoring and documentation as well.
This would mean that Indian pharmaceutical companies would have to incur additional investment in these areas and this would also add to the cost of manufacturing the medicines.
All these aspects has left the largest supplier of medicines (India) at the mercy of the world’s largest consumer and regulator of medicines (USA).
____________________________________________________________________________________________________
Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/