Negotiations Regarding the Drugs Amendment Act, 2017

THROUGH EMAIL

PPMA CIRCULAR NO.  164/2017

March 26, 2017

TO:        ALL MEMBER COMPANIES OF PPMA

Subject: NEGOTIATIONS REGARDING THE DRUGS (AMENDMENT ACT, 2017 

Dear Members,

As per directives of Chairman PPMA Dr. Shaiekh Kaiser Waheed Sahab, I am forwarding the below email from our honourable CEC member Mr. Haroon Qassim Sahab regarding the subject matter, for your kind information, please.

Warm Regards

NAWAZ AHMED

Secretary General

PPMA(Pakistan Pharmaceutical Manufacturers Association)
Cell  +300 8592400
L.L   +51 4435103

Fax  +51 4435104

From: “Haroon Qassim”
Subject: Punjab – NEGOTIATIONS REGARDING THE DRUGS (AMENDMENT) ACT, 2017

NEGOTIATIONS REGARDING THE DRUGS (AMENDMENT) ACT, 2017

The Punjab Govt. was represented by the Minister and Secretary of Primary & Secondary Healthcare Department along with other junior officials. The stakeholders presented their objections to the amendments and, barring a few provisions, almost the whole draft was discussed threadbare. The remaining portion was agreed to be discussed in the subsequent meeting.
Following is the brief summary of the salient features of discussion:
1.    The definition of spurious drugs would remain unchanged.

2.    A new category of offences covering minor aberrations from the prescribed norms such as friability, dissolution, misbranding, colour fading etc. would be created under the heading “out of specifications”. There would be no prosecution and imprisonment for such offences and in most cases recall (whether voluntary or on the instructions of the regulator) would be sufficient. The prosecution may be initiated if the company fails to recall despite clear instructions.

3.    We had discussions over the procedure and definition of “Recall” and there was an agreement that in this regard, US FDA definitions may be used as a reference.

4.    It was agreed that the time to be given for the recall of drugs is to be a minimum of two weeks. Government authorities contended that different slabs of time should be prescribed for different types of drugs needing recall, and the drugs needing urgent recall must be recalled urgently.

5.    Four categories of sub-standard drugs agreed with limits (0-5%; 5-15%; 15-50%; and > 50%) and fines and punishments. The limits would be with respect to the amount of API present in the drug. However, no mandatory imprisonment or minimum fines as was proposed in the Amendment Act.

6.    It was agreed between the parties that punishment for subsequent offences should be for the same drugs.

7.    There was an agreement to remove the newly added Clause 23 A regarding “aiding, abetting and association in contravention of the Act”.

8.    Also agreed to remove the newly added 23 B regarding “prohibition of acquisition and possession of assets derived from contravention of the Act”.

9.    There was an agreement on removing the newly added 27(5) which pertained to the prosecution of drug inspectors and officials of DTLs.

10.    Objection was raised by PPMA over the powers given to Provincial Authorities for suspension of license. Government Authorities contended that they are amenable to the discussion of reducing the period during which the license can be suspended but was unwilling to do away with this power altogether.

11.    On the matter regarding independent inspectors and monitoring teams, there was disagreement over the contention of the stakeholders that they should not have police powers and they should only have an advisory role. The government authorities left it to the discretion of the law minister.

12.    It was also agreed that the amount of fine to a pharmacy or point of sale will be limited to 3 times of the stock in question. Moreover, if a chemist has the warranty he will be exempted from prosecution. If the warranty chain is broken he will be liable where the warranty chain is broken.

13.    There also was a long discussion over the treatment of adulterated drugs as these had been put in Section 27(1) along with heinous offences like manufacturing without a license and spurious drugs. However, there is still a disagreement on this issue. It was agreed that a classification system should be introduced for the calculation of the level of adulteration in the drugs. Clauses are to be introduced which will differentiate adulteration of a critical from minor adulterations.

14.    The stakeholders also recommended that consultation should be PIC-S certified and it should have an advisory role. However, this needs further discussion.

15.    There were detailed discussions over the addition of the offence of storing temperature-sensitive drugs under wrong conditions and its punishment under Section 27(1). The provision has been introduced to punish the manufacturing or transport of temperature-sensitive drugs in conditions that the drug may lose its potency. The stakeholders proposed that storage or transport against the prescribed temperature should only be punished with a fine and that the temperature limits of USP 38 may be followed. They further explained that apart from 2-8 °C drugs, all medicines go through rigorous stability testing, and short term spikes of temperature do not harm the quality and efficacy of drugs. The Government representatives suggested and agreed that if the company has the documents regarding exposure on temperature range then it will be accepted. However, it has been agreed that thermolabile products should be covered under Section 27 (1), while temperature-controlled products will be covered under Section 27 (4).

16.    With respect to the offence regarding absence from PQCB, the government authorities refused to accept any amendment.

17.    The provision regarding false statements, Section 30 (all offences made cognizable and non-bailable) is to be discussed with the Law Minister.