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The Indian Drug Manufacturers' Association- Gujarat State Board (IDMA-GSB) is actively pushing for extension of the WHO GMP certification from 2 years to minimum 5 years. The association strongly believes that this measure is essential to ensure hassle free trade in the semi-regulated market amidst cut-throat competition from China.
This demand comes in the wake of growing concern raised by the industry over the short validity of the certification, which is putting undue pressure on the industry to go for its renewal every two years. This was deliberated during a high level meeting with the Drug Controller General of India (DCGI) Dr G N Singh that was concluded in Gujarat last week.
IDMA-GSB informed that to ease Indian pharma companies' woes in this market especially with mounting Chinese pressure, the Indian regulators should contemplate extending the WHO GMP validity further. It is understood that the DCGI was apprehensive about commenting on extending its validity to 5 years, drawing attention to the fact that India’s brand recognition is much higher than that of China in the global market.
However, sources inform that as a reprieve he did hint on the possibility of extending the validity of the same for at least 3 years provided that it is approved as per the WHO guidelines.
Other key issue that was raised by the industry was their apprehension to comply with the center’s proposed plan to replace gelatin capsules with cellulose based capsules. Cellulose based capsules are of plant origin and considered safe for use as compared to animal-based gelatine capsules.
Viranchi Shah, vice chairman of the IDMA-GSB informed that the industry is in utter chaos over this matter, as it will have huge impact over the business in the near future. “A lot is at stake here especially since this move may lead to shortage of this drugs in the market, due to reasons like lack of cost effectiveness etc to the company. Also, there is not clear established proof on the safety of this cellulose capsules compared to the gelatin that has been used over years. We hope that the government will take action only after looking into all the parameters as it will have a huge impact on the business,” he pointed out.
He further informed that they also raised the issue of ban on PET bottles with the DCGI as it is yet another burning topic affecting the interest of the stakeholders. Shah pointed out that considering that PET bottles are considered safe and are used world wide for pharmaceutical use, it will be unwise to ban them in the country based on some random study done by the said NGO. He suggested that due consideration should be given on analyzing technical data and similar studies in other countries as well before taking any decisions. Especially since countries like US, EU etc still use PET bottles for pharma packaging.
“Dr Singh has agreed to look into this matter and has assured to pass on our recommendation to the requisite committee for their consideration. We are sure that the Centre will come out with a logical conclusion after weighing all the pros and cons to ensure that the confidence of the industry is not shattered in the due process,” he added.
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