Photo: AFP
Photo: AFP

Govt accepts report backing PET bottles for pharma products

Of the 600,000 tonnes of PET produced, the pharmaceutical industry uses around 16%, accounting for around 100,000 tonnes every year

New Delhi: The ministry of health and family welfare and the ministry of environment have accepted a report which finds polyethylene terephthalate, or PET, bottles to be safe for pharmaceutical packaging.

Lawyers representing both ministries have accepted a report on the health and environmental impact of plastic containers as packaging material for drug formulations at the National Green Tribunal (NGT) this week.

“We have accepted the report. Ministry officials were part of the report. The case is posted for final arguments on 23 and 24 May," said Vikas Malhotra, a lawyer, who represented the environment ministry.

A high-level committee headed by M.K. Bhan, former secretary in the department of biotechnology, under the ministry of science and technology, submitted its report in March this year.

“There is no conclusive, reproducible evidence to suggest that use of PET or additive used with it such as antimony for pharmaceutical packaging may leach substances beyond limits that pose threat to human health," the report submitted to the green tribunal said.

The development comes as a major relief to the 4,000 crore PET packaging industry.

Of the 600,000 tonnes of PET produced, the pharmaceutical industry uses around 16%, accounting for around 100,000 tonnes every year.

In 2013, Him Jagriti, an Uttarakhand-based non-governmental organization (NGO) that works in the health sector, approached the Union ministry of health seeking a ban on the usage of PET for pharmaceutical packaging.

The central government had entrusted the Drugs Technical Advisory Board (DTAB), the highest decision-making body under the ministry on technical matters, to take a call.

Following this, a test conducted by the All India Institute of Hygiene and Public Health (AIIHPH), which is affiliated to the health ministry, was taken into consideration.

According to the minutes of a DTAB meeting, AIIHPH got five different pharmaceutical preparations packaged in PET bottles tested at the National Test House in Kolkata, which comes under the Union ministry of consumer affairs.

The tests revealed that the levels of toxic chemicals were higher than safety limits. The DTAB minutes state that antimony, chromium, lead and diethylhexyl phthalate were present at room temperature in all five samples.

Based on this study, the ministry had come out with a draft notification prohibiting the use of PET for pharmaceutical packaging last year.

This was put on hold following industry pressure. Subsequently, Him Jagriti approached the National Green Tribunal seeking a blanket ban on the use of PET bottles.

The report by the expert committee states, “Within a robust regulatory system and process with clearly defined standards and requirements, the use of PET as a packaging material for pharmaceuticals can be practiced with assurance of safety."

The report further adds that PET does not require use of phthalates or any plasticizers in the manufacturing process.

Interestingly, the committee in its report says that treated soda lime glass and regular soda lime glass is susceptible to leaching.

“Treated soda lime glass is characterized by high hydraulic resistance and is more susceptible to leaching than borosilicate glass," the report states.

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