India boasts of being the third largest pharmaceutical industry in the world exporting pharma products to over 200 countries and aiming to become a $55 billion industry by 2020.
The galore of opportunity that is currently unfolding can take Indian pharmaceutical industry to new heights. There are several drugs that are going off patent by 2020 and if Indian companies innovate and develop new drugs, they can capture a huge chunk of the global industry.
However, one of the biggest hurdles faced by the Indian pharmaceutical industry today is to comply with various foreign regulations by incorporating good manufacturing practices (GMP) in every quarter of the supply chain.
According to Assocham, the standards of GMP in many production plants in India fall well below the standards typically observed by international plants especially in Europe and US. Among 5,000 observations of deficiencies included inadequacy of CAPAs, deviation procedures lacking insufficient details, management failing to ensure an effective quality system and issues related to change controls like lack of post-implementation review of effectiveness, etc.
“India continues to be the largest exporter of generic drugs to the US and even in this year, over 40 percent of the new drug approvals were from India. India still has the largest number of facilities approved by US and other countries. However, there have been concerns about compliance and the industry is actively addressing it. Most companies who export are aware of the requirements, the expectations are no doubt very stringent and industry needs to be up to date and always prepared. The CDSCO and local drug authorities are also raising the bar on their expectations which is a good move as this will help companies to raise their levels,” said Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Association.
Recently, data integrity scrutiny has been increased not just in the US but also in Europe, Asia and Australia among other territories. Hence it becomes very important for Indian companies to comply with the global standards and avoid these data integrity problems which break trust with the foreign counterparts.
“As far as quality is concerned, things are getting tougher by the day. Most of the notices and problems that are arising are not always because of a failing product but because of data integrity issues that are being spotted by the USFDA. Every country has its own quality systems and standards. If we are to export to a particular country, it is imperative to comply with their regulations. However, India has its own Schedule M in place which is as good as WHO GMP and if that is properly implemented, most of the clauses are taken care of,” said Vinod Kalani, president, Rajasthan Pharmaceutical Manufacturers Association and co-chairman of Federation of Pharma Entrepreneurs (FOPE).
GMP lapses
Recently, several major Indian pharmaceutical companies came under the radar of various foreign regulators who revoked their licences due non-compliance with GMP.
India’s largest drug maker, Sun Pharma, was recently mauled by the US Food and Drug Administration (FDA) over lax quality control at its plants and not following good manufacturing practices. The USFDA had found 11 quality lapses at the company’s Dadra unit, which included incomplete laboratory records, failure to create accurate duplicates of key records, and improper investigation of drug batches that did not meet specifications, etc. Later the company succeeded in getting a clearance from the USFDA earlier this year. The US FDA this year also lifted an import ban on Sun Pharma’s Mohali manufacturing plant in Punjab which was issued in 2013. However, the company’s plant at Halol in Gujarat is still under a warning letter from the US regulator while other few other plants are under import alert.
French National Agency for Medicines and Health Products Safety, which inspected Biocon's Bengaluru plant on behalf of the European Medicine Agency (EMA) earlier this year found 35 deficiencies, including 11 major deficiencies at Biocon's Bommasandra facility in Bengaluru with respect to GMP for activities related to three biosimilar products namely— Fulphila (Pegfilgrastim), Ogivri (Trastuzumab) and Semglee (Insulin Glargine) — for marketing authorisation in European Union. The regulator proposed suspension of marketing authorisation and prohibition of supply of the three products until the deficiencies are resolved.
Lupin Ltd came under the US FDA scanner and was served the Form 483 after it noticed eight violations of GMP in the Aurangabad unit which include a lack of proper investigation of market complaints and adverse drug experiences, a lack of written review procedure for stored data, ineffective testing of finished products, and a lack of certain processes to control contamination. The US FDA cited three observations related to violation of norms in Lupin’s Goa as well.
Aurobindo Pharma Ltd’s Hyderabad unit was also pulled up for seven violations recently by the regulator. The regulator noticed two key lapses: there were not enough controls over computers and who accessed them, and lack of procedures to prevent microbiological contamination of products purporting to be sterile. The FDA also observed that buildings and manufacturing were not maintained in a good state.
Read more: Putting GMP in place
India boasts of being the third largest pharmaceutical industry in the world exporting pharma products to over 200 countries and aiming to become a $55 billion industry by 2020.
The galore of opportunity that is currently unfolding can take Indian pharmaceutical industry to new heights. There are several drugs that are going off patent by 2020 and if Indian companies innovate and develop new drugs, they can capture a huge chunk of the global industry.
However, one of the biggest hurdles faced by the Indian pharmaceutical industry today is to comply with various foreign regulations by incorporating good manufacturing practices (GMP) in every quarter of the supply chain.
According to Assocham, the standards of GMP in many production plants in India fall well below the standards typically observed by international plants especially in Europe and US. Among 5,000 observations of deficiencies included inadequacy of CAPAs, deviation procedures lacking insufficient details, management failing to ensure an effective quality system and issues related to change controls like lack of post-implementation review of effectiveness, etc.
“India continues to be the largest exporter of generic drugs to the US and even in this year, over 40 percent of the new drug approvals were from India. India still has the largest number of facilities approved by US and other countries. However, there have been concerns about compliance and the industry is actively addressing it. Most companies who export are aware of the requirements, the expectations are no doubt very stringent and industry needs to be up to date and always prepared. The CDSCO and local drug authorities are also raising the bar on their expectations which is a good move as this will help companies to raise their levels,” said Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Association.
Recently, data integrity scrutiny has been increased not just in the US but also in Europe, Asia and Australia among other territories. Hence it becomes very important for Indian companies to comply with the global standards and avoid these data integrity problems which break trust with the foreign counterparts.
“As far as quality is concerned, things are getting tougher by the day. Most of the notices and problems that are arising are not always because of a failing product but because of data integrity issues that are being spotted by the USFDA. Every country has its own quality systems and standards. If we are to export to a particular country, it is imperative to comply with their regulations. However, India has its own Schedule M in place which is as good as WHO GMP and if that is properly implemented, most of the clauses are taken care of,” said Vinod Kalani, president, Rajasthan Pharmaceutical Manufacturers Association and co-chairman of Federation of Pharma Entrepreneurs (FOPE).
GMP lapses
Recently, several major Indian pharmaceutical companies came under the radar of various foreign regulators who revoked their licences due non-compliance with GMP.
India’s largest drug maker, Sun Pharma, was recently mauled by the US Food and Drug Administration (FDA) over lax quality control at its plants and not following good manufacturing practices. The USFDA had found 11 quality lapses at the company’s Dadra unit, which included incomplete laboratory records, failure to create accurate duplicates of key records, and improper investigation of drug batches that did not meet specifications, etc. Later the company succeeded in getting a clearance from the USFDA earlier this year. The US FDA this year also lifted an import ban on Sun Pharma’s Mohali manufacturing plant in Punjab which was issued in 2013. However, the company’s plant at Halol in Gujarat is still under a warning letter from the US regulator while other few other plants are under import alert.
French National Agency for Medicines and Health Products Safety, which inspected Biocon's Bengaluru plant on behalf of the European Medicine Agency (EMA) earlier this year found 35 deficiencies, including 11 major deficiencies at Biocon's Bommasandra facility in Bengaluru with respect to GMP for activities related to three biosimilar products namely— Fulphila (Pegfilgrastim), Ogivri (Trastuzumab) and Semglee (Insulin Glargine) — for marketing authorisation in European Union. The regulator proposed suspension of marketing authorisation and prohibition of supply of the three products until the deficiencies are resolved.
Lupin Ltd came under the US FDA scanner and was served the Form 483 after it noticed eight violations of GMP in the Aurangabad unit which include a lack of proper investigation of market complaints and adverse drug experiences, a lack of written review procedure for stored data, ineffective testing of finished products, and a lack of certain processes to control contamination. The US FDA cited three observations related to violation of norms in Lupin’s Goa as well.
Aurobindo Pharma Ltd’s Hyderabad unit was also pulled up for seven violations recently by the regulator. The regulator noticed two key lapses: there were not enough controls over computers and who accessed them, and lack of procedures to prevent microbiological contamination of products purporting to be sterile. The FDA also observed that buildings and manufacturing were not maintained in a good state.
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