Putting GMP in place

Putting GMP in place

10:59 AM, 21st November 2017
Indian pharmaceutical industry
The galore of opportunity that is currently unfolding can take Indian pharmaceutical industry to new heights. (File photo)

By Debarati Das

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.

Dr Reddy’s German subsidiary Betapharm Arzneimittel was mauled by the Regulatory Authority of the Germany (Regierung von Oberbayern) and revoked its GMP compliance certificate of the company’s formulations manufacturing unit -2 in Bachupally near Hyderabad. The company’s two plants including the Srikakulam API unit called CTO-6 and Duvvada oncology and harmonal injectable facility in Andhra Pradesh were also under US FDA warning letter.

While some feel that the laws are too being made to stringent to follow, other manufacturers feel that small issues are being pecked up to be made into a major violation. But there are also others who feel that the country’s pharma industry should raise their standards and first judiciously implement the already existing Indian regulations.

“The attitude of people needs to change. There are procedures and they need to be followed. Quality shouldn’t be compromised to make way for building business. The company management should be quality conscious and make this the attitude of every person working in the company,” said Suresh Kamath, Vice President, Goa Pharmaceutical Manufacturers Association.  “While Schedule M is more than sufficient for GMP, the government enforcement agencies that conduct inspections should be well equipped and trained to conduct inspections the way it is done by the foreign inspectors.”

“In India, we should have our own standards as per our ground reality instead of copying them. What works for US or Europe may not be viable in Indian situation. And by making the standards very rigid, very few people will be able to manufacture while the rest will be forced to move out of the competition,” opined Kalani.

Changing manufacturing practices

If the industry aims to capture the global market, there are certain things that need to be done on pronto. 

  • It is high time that the country’s pharma industry set criteria in quality production for global drug sector.
  • Along with skills development, modernisation of production plants is a necessity.
  • There is a need for single standard rather than multiple regulations to govern quality yardstick.
  • Continuous improvement, upgradation and use of self-assessment should be made a part of the system.
  • Since most of the problems arise due to data integrity, it is important that companies invest time and resources in design of documents, systems and products.

Good manufacturing practices should not be an exclusive entity for export items which is dusted out of the cupboards when foreign regulators come home. It should be a part of every manufacturing parameter to quantify quality.

“We have to move from preparing for audit to being always prepared for one. We have to move from being compliance driven to become customer focused, build quality in our design, make risk assessment and management an integral part of our quality management system. But most of all, we have to bring pride in the profession of a pharmacist and make it a career of choice,” said Attavar.

© Chemical Today Magazine


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