In the 71st meeting of the Drugs Technical Advisory Board (DTAB) recommended that there is no need to indicate vegetarian on cellulose based capsules. They also recommended prohibiting the use PET/ plastic bottles for primary packaging of certain liquid drug formulations.
At the minutes of meeting there was an agenda to consider the proposal and to incorporate the labelling of cellulose capsules with a green dot under the provisions of the Drugs and Cosmetics Act 1945. The green dot indication would distinguish the cellulose capsule as vegetarian and distinct from other normally available capsules which are gelatine based. This would help consumers to be well informed about the origin of the capsules.
Cellulose based capsules have been permitted to be manufactured in India on the basis of the permission granted from the office of the DVG (I) for manufacture of such capsules as ‘new drug.’ The proposal of a monograph of cellulose based capsule in the Indian Pharmacopoeia is under consideration by the Indian Pharmacopoeia Commission and it is in the process of finalisation after considering the comments from various stakeholders.
The proposal was to mark the cellulose capsules with a green dot to indicate its vegetarian origin while the gelatine based capsule was to continue to be marketed without any additional labelling. The members discussed the issue and came to the opinion that drugs were different from foods because unlike foods, consumers do not take drugs by choice. Drugs are prescribed by doctors to save lives and marking them vegetarian and non-vegetarian is therefore not desirable. The members also pointed out that the HPMC capsules are basically of synthetic origin and as such cannot be considered as purely vegetarian origin as in the case of food preparations. Therefore after making deliberations the DTAB did not agree to the proposal of labelling cellulose capsules with a green dot.
Banning of PET/ plastic packaging
Another agenda item that was considered was the issue of banning of packaging of pharmaceutical products in PET/ plastic bottles. The members were apprised that the issue of prohibiting the use of plastic/ PET containers in pharmaceutical products was put forth for consideration by the DTAB in view of reports of harmful effects of leaching of chemicals from the plastic bottles into the contents on long storage. It was recommended then that in the first phase the use of plastic/PET containers in liquid oral consumption for primary packaging of paediatric formulations, as well as formulations meant for geriatrics, women in reproductive age group and pregnant women would be phased out and then banned. The pharmaceutical industry was to be given an adequate time of six months to change over.
A Gazette notification G.S.R 701(E) dated 29/09/14 was issued by the Government of India for amendment under the Drugs and Cosmetics Rules 1945. This notification prohibited the use of Polyethylene Terephthalate (PET) in liquid oral formulations for primary packaging of drug formulations and any manufacturer that contravened the provision was liable to be penalised according to the provisions of the Drugs and Cosmetics Act 1940.
After this proposal a number of comments were received by the Government on the drafted rules especially from PET manufacturer’s associations who raised objections to the notification. Since the number of representations was large the Ministry of Health and Family Welfare consulted a committee under the Chairmanship of Prof. MK Bhan, Former Secretary, Department of Biotechnology, Ministry of Science and Technology to assess the health and environmental impact of use of PET or plastic containers for primary packaging of drug formulations.
The matter was discussed in the 70th meeting in light of the study that was conducted at the All India Institute of Hygiene and Public Health. Samples of the five different pharmaceutical preparations packaged in PET bottles were subjected to testing at the National Test House, Kolkata. The following chemicals were found
These chemicals were present even at room temperature in all five samples. The concentration increased on exposure to higher temperature in the laboratory. The committee recommended that the issue of cumulative exposure also needed to be addressed through more comprehensive toxicological/ toxicokinetic studies. The committee however, reiterated its recommendation that PET should be banned in vulnerable groups as leaching was more than safe levels even at room temperature. These findings were forwarded to the Government of India for consideration.
Dr. RN Chaudhuri Director, All India Institute of Hygiene and Public Health, Kolkata was invited to the meeting to present the detailed study and he submitted the ‘Report of Plastic Hazard Committee’ which was prepared in collaboration with the National Test House, Kolkata. The study also took into consideration the recommendations of the ICMR as well as observations of the Dr. MK Bhan Committee seeking clarifications in respect of methods of estimation adopted, sample size etc. by the AllH&PH. It has been clarified in the report that AllH&PH had used
- Optical Emission Spectrometry,
- Gas Chromatography,
- Mass Spectrometry and
- Atomic Absorption Spectrometer
The sample size consisted of three bottles of the product of the same batch number at three different temperatures, room temperature, temperature at 40ºC and temperature at 60ºC after incubation of 10 days. The report concluded that extreme caution must be taken for packaging pharmaceuticals for vulnerable sections like infants, children, nursing and expectant mothers and elderly group.
The DTAB members agreed that leaching does indeed take place in liquid oral preparations and it increases at higher temperature. In India there is a wide variation of temperatures which may go as high as 45 to 48 ºC and chances of leaching then increases further. Small dozes may not show immediate harmful effects but continuous exposure especially to the vulnerable groups is a matter of concern.
DTAB members agreed with the findings of AIIH&PH, Kolkata and also on the testing methods adopted by the National test House Kolkata. Based on this evidence the DTAB after deliberations recommended that the report be forwarded to the Ministry of Health and Family Welfare for consideration and finalisation of draft rules to prohibit the use of Polyethylene Terephthalate or plastic containers in the liquid oral formulations for primary packaging of drug formulations for paediatric, geriatric use and for use of pregnant women and women in the reproductive age group. Dr. Nilima Kshirasagar further suggested that besides the four elements mentioned above, other elements also leach into pharmaceutical formulations, for which study should be carried out.